Baby Orajel Tooth & Gum Cleanser, Mixed Fruit (2006 formulation) || Skin Deep: Cosmetic Safety Reviews

BABY ORAJEL TOOTH & GUM CLEANSER, MIXED FRUIT (2006 FORMULATION)

last updated: 05/01/06 brand: Baby Orajel by Del Pharmaceuticals, Inc.

SCORE

moderate hazard (out of 10)

75%

data gap

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94% of baby toothpastes have lower concerns

COMPANY POLICIES

Compact for Safe Cosmetics
Non-signer: This company has not signed the Compact.

Animal Testing Policy
This company's animal testing policy is unknown.

Given the incomplete information made available by companies and the government, EWG provides additional information on personal care product ingredients from the published scientific literature. The chart below indicates that research studies have found that exposure to one or more ingredients in this product -- not the product itself -- caused the indicated health effect(s) in the studies reviewed by Skin Deep researchers. Actual health risks, if any, will vary based on the level of exposure to the ingredient and individual susceptibility -- information not available in Skin Deep.

Ingredients in this product are linked to:
	Cancer
	Developmental/reproductive toxicity
	Violations, restrictions & warnings
	Allergies/immunotoxicity
	Other concerns for ingredients used in this product: Neurotoxicity, Endocrine disruption, Organ system toxicity (non-reproductive), Miscellaneous, Irritation (skin, eyes, or lungs), Enhanced skin absorption, Occupational hazards, Biochemical or cellular level changes

Ingredients from packaging: ACTIVE INGREDIENTS: MICRODENT (POLOXAMER 407 2%; SIMETHICONE 0.12%. INACTIVE INGREDIENTS: CARBOXYMETHYLCELLULOSE SODIUM, CITRIC ACID, FLAVOR, GLYCERIN, METHYLPARABEN, POTASSIUM SORBATE, PROPYLENE GLYCOL, PROPYLPARABEN, PURIFIED WATER, SODIUM SACCHARIN, SORBITOL.

Directions from packaging: Do not use if tube tip is cut prior to opening. Wash hands. Cut open tip of tube. Place finger toothbrush securely on index finger. Apply Baby Orajel Tooth and Gum Cleanser to the bristles of the brush. Gently brush your baby's teeth and gums to remove food and plaque-like film. For best results use twice daily (morning and at bedtime).

Warnings from packaging: When using this product do not leave your baby unattended with finger toothbrush. Keep out of the reach of children.

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ingredients

	score	data gap	concerns
METHYLPARABEN	10	63%	Violations, restrictions & warnings, Endocrine disruption, Allergies/immunotoxicity, Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs), Biochemical or cellular level changes
PROPYLPARABEN	5	71%	Developmental/reproductive toxicity, Endocrine disruption, Allergies/immunotoxicity, Organ system toxicity (non-reproductive)
FLAVOR	4	100%	Miscellaneous
PROPYLENE GLYCOL	4	60%	Allergies/immunotoxicity, Organ system toxicity (non-reproductive), Irritation (skin, eyes, or lungs), Enhanced skin absorption
CITRIC ACID	3	72%	Violations, restrictions & warnings, Organ system toxicity (non-reproductive)
SODIUM SACCHARIN	2	80%	Neurotoxicity
GLYCERIN	2	74%	Organ system toxicity (non-reproductive), Occupational hazards
SORBITOL	1	88%	none identified
POTASSIUM SORBATE	1	85%	none identified
CELLULOSE GUM CARBOXYMETHYLCELLULOSE SODIUM	1	80%	none identified
POLOXAMERS POLOXAMER (407,2%) (Active Ingredient)	0	100%	none identified
SIMETHICONE (Active Ingredient)	0	100%	none identified
WATER	0	0%	innocuous

Cancer*

*This table includes all possible cancer concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
One or more animal studies show tumor formation at high doses		CELLULOSE GUM
One or more in vitro tests on mammalian cells show positive mutation results		SORBITOL, SODIUM SACCHARIN, PROPYLPARABEN, PROPYLENE GLYCOL, POTASSIUM SORBATE, GLYCERIN, METHYLPARABEN

Developmental/reproductive toxicity*

*This table includes all possible developmental/reproductive toxicity concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
One or more animal studies show reproductive effects at moderate doses		PROPYLENE GLYCOL
One or more animal studies show reproductive effects at high doses		SODIUM SACCHARIN
One or more animal studies show reproductive effects at moderate doses		GLYCERIN, CELLULOSE GUM
One or more animal studies show any effects at low doses		PROPYLPARABEN

Violations, restrictions & warnings*

*This table includes all possible violations, restrictions & warnings concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Determined safe for use in cosmetics, subject to concentration or use limitations - Safe for use in cosmetics with some qualifications		PROPYLENE GLYCOL
Violation of government restrictions - Banned or found unsafe for use in cosmetics		METHYLPARABEN
Restricted in cosmetics (recommendations or requirements) - use, concentration, or manufacturing restrictions - Use is restricted in Canadian cosmetics		CITRIC ACID

Neurotoxicity*

*This table includes all possible neurotoxicity concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
One or more animal studies show brain and nervous system effects at moderate doses		METHYLPARABEN
One or more animal studies show brain and nervous system effects at high doses		PROPYLENE GLYCOL, POTASSIUM SORBATE, GLYCERIN
One or more animal studies show brain and nervous system effects at very low doses		SODIUM SACCHARIN

Endocrine disruption*

*This table includes all possible endocrine disruption concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Human any disruptor - strong evidence		PROPYLPARABEN
One or more animal studies show endocrine system disruption at high doses		GLYCERIN
Human any disruptor - strong evidence		METHYLPARABEN

Allergies/immunotoxicity*

*This table includes all possible allergies/immunotoxicity concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Limited evidence of skin and immune system toxicity		PROPYLENE GLYCOL
Human skin toxicant - strong evidence		PROPYLPARABEN, METHYLPARABEN

Organ system toxicity (non-reproductive)*

*This table includes all possible organ system toxicity (non-reproductive) concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
One or more animal studies show gastrointestinal effects at high doses (low dose studies may be unavailable for this ingredient)		SORBITOL, SODIUM SACCHARIN, CELLULOSE GUM
One or more animal studies show sense organ effects at moderate doses (low dose studies may be unavailable for this ingredient)	products for use around the eyes, mouth, or lips	PROPYLENE GLYCOL
One or more animal studies show broad systemic effects at moderate doses (low dose studies may be unavailable for this ingredient)		POTASSIUM SORBATE
One or more animal studies show sense organ effects at very low doses	products for use around the eyes, mouth, or lips	CITRIC ACID
Limited evidence of sense organ toxicity		PROPYLPARABEN
One or more animal studies show kidney or renal system effects at very low doses		GLYCERIN
Known human any toxicant		METHYLPARABEN

Miscellaneous*

*This table includes all possible miscellaneous concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Ingredient not fully labeled - identity unknown		FLAVOR

Ecotoxicology*

*This table includes all possible ecotoxicology concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Wildlife and environmental toxicity		PROPYLPARABEN

Irritation (skin, eyes, or lungs)*

*This table includes all possible irritation (skin, eyes, or lungs) concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
One or more animal studies show skin irritation at moderate doses		GLYCERIN, CITRIC ACID
One or more animal studies show skin irritation at low doses		METHYLPARABEN
Classified as skin irritant		PROPYLENE GLYCOL

Data gaps*

*This table includes all possible data gaps concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Risk assessment method deficiencies and data gaps - Maximum reported "as used" concentration is basis of safety assessment by industry safety panel (Cosmetic Ingredient Review, CIR) - implicit safe concentration limit in product		PROPYLPARABEN
Safety assessment was based on related chemical		PROPYLENE GLYCOL
Risk assessment method deficiencies and data gaps - Maximum reported "as used" concentration is basis of safety assessment by industry safety panel (Cosmetic Ingredient Review, CIR) - implicit safe concentration limit in product		POTASSIUM SORBATE, METHYLPARABEN
Not assessed for safety in cosmetics by industry panel		SIMETHICONE, SODIUM SACCHARIN, SORBITOL, FLAVOR
Risk assessment method deficiencies and data gaps - Maximum reported "as used" concentration is basis of safety assessment by industry safety panel (Cosmetic Ingredient Review, CIR) - implicit safe concentration limit in product		CELLULOSE GUM
Not assessed for safety in cosmetics by industry panel		POLOXAMERS, GLYCERIN, CITRIC ACID

Occupational hazards*

*This table includes all possible occupational hazards concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Allowed workplace exposures restricted to moderate doses		GLYCERIN

Biochemical or cellular level changes*

*This table includes all possible biochemical or cellular level changes concerns for the ingredients used by this manufacturer. Some categorizations depend on how the product is used or formulated.

type of concern	product conditions	ingredient(s)
Interferes with gene expresion		METHYLPARABEN
One or more animal studies show biochemical changes at high doses where the human health implications are not yet well understood		CITRIC ACID, GLYCERIN, PROPYLENE GLYCOL, CELLULOSE GUM