Orajel Denture plus Gel (2006 formulation) || Skin Deep: Cosmetic Safety Reviews

ORAJEL DENTURE PLUS GEL (2006 FORMULATION)

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

SCORE

moderate hazard (out of 10)

76%

data gap

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75% of denture cares have lower concerns
76% of pain reliefs 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: Organ system toxicity (non-reproductive), Miscellaneous, Multiple, additive exposure sources, Irritation (skin, eyes, or lungs), Enhanced skin absorption, Occupational hazards

Ingredients from packaging: ACTIVE INGREDIENTS: BENZOCAINE 15%; MENTHOL 2%. INACTIVE INGREDIENTS: ACESULFAME POTASSIUM; ETHYL ALCOHOL 66.7% BY WEIGHT; ETHYLCELLULOSE; FLAVOR; POLYCARBOPHIL; PURIFIED WATER.

Warnings from packaging: Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. Flammable: keep away from fire or flame. Avoid smoking during the application and until product has dried. Do not use: more than directed; for more than 7 days unless told to do so by a dentist or doctor. Stop use and ask a doctor if: sore mouth symptoms do not improve in 7 days; swelling, rash or fever develops; irritation, pain or redness persists or worsens. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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ingredients

	score	data gap	concerns
BENZOCAINE (Active Ingredient)	7	61%	Violations, restrictions & warnings, Allergies/immunotoxicity, Organ system toxicity (non-reproductive)
ETHANOL ETHYL ALCOHOL BY WEIGHT	5	74%	Cancer, Developmental/reproductive toxicity, Organ system toxicity (non-reproductive), Multiple, additive exposure sources, Irritation (skin, eyes, or lungs), Enhanced skin absorption, Occupational hazards
FLAVOR	4	100%	Miscellaneous
MENTHOL (Active Ingredient)	3	85%	Organ system toxicity (non-reproductive), Multiple, additive exposure sources
ETHYLCELLULOSE	1	94%	Organ system toxicity (non-reproductive)
POLYCARBOPHIL	0	100%	none identified
POTASSIUM ACESULFAME ACESULFAME POTASSIUM	0	94%	none identified
WATER (PURIFIED)	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 in vitro tests on mammalian cells show positive mutation results		MENTHOL
Cancer - limited evidence		ETHANOL

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)
Limited evidence of reproductive toxicity		ETHANOL

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)
Violation of government restrictions - Banned or found unsafe for use in cosmetics		BENZOCAINE

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)
nervous system - weight of evidence unknown/unassessed/unreview: published lit review or major tox study		ETHANOL
One or more animal studies show brain and nervous system effects at moderate doses		MENTHOL
One or more animal studies show brain and nervous system effects at high doses		BENZOCAINE

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)
Known human immune system toxicant		BENZOCAINE

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 sense organ effects at very low doses	products for use around the eyes, mouth, or lips	MENTHOL
One or more animal studies show blood effects at low doses		BENZOCAINE
Classified as expected to be toxic or harmful		ETHYLCELLULOSE
One or more animal studies show sense organ effects at very low doses	products for use around the eyes, mouth, or lips	ETHANOL

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)
Occupational hazards related to handling		ETHANOL
Ingredient not fully labeled - identity unknown		FLAVOR

Multiple, additive exposure sources*

*This table includes all possible multiple, additive exposure sources 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)
Designated as safe for general or specific, limited use in food		POTASSIUM ACESULFAME, MENTHOL, ETHYLCELLULOSE, ETHANOL
Used in food or as an additive with limited or no toxicity information available		MENTHOL, ETHANOL

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		MENTHOL, ETHYLCELLULOSE, BENZOCAINE
One or more animal studies show skin irritation at low doses		ETHANOL

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)
Not assessed for safety in cosmetics by industry panel		FLAVOR, POTASSIUM ACESULFAME, POLYCARBOPHIL, MENTHOL, ETHYLCELLULOSE, ETHANOL, BENZOCAINE

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 high doses		ETHANOL

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)
One or more animal studies show biochemical changes at high doses where the human health implications are not yet well understood		ETHANOL