CARE ONE MEDICATED LIP BALM IN A POT- petrolatum ointment
American Sales Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Petrolatum

Purpose

Skin Protectant

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center immediately. Do not induce vomiting before contacting a Poison Control Center.

Uses

Helps prevent and temporarily protect dry and chapped lips.

Warnings

For external use only: When using this product: avoid contact with eyes. Rinse with water to remove. Stop use and consult a doctor if: condition worsens or lasts more than 7 days. Do not induce vomiting before contacting a Poison Control Center. For adults and children over 2 years of age.

Directions

Apply liberally and evenly. Reapply as needed.

Inactive Ingredients

Synthetic Beeswax, Mineral Oil, Microcrystalline Wax, Lanolin, Camphor, Copernicia Cerifera (Carnauba) Wax, Menthol, Theobroma Cacao (Cocoa) Seed Butter, Salicylic Acid, Phenol, Flavor

Package/Label Principal Display Panel

CARE ONE MEDICATED LIP BALM IN A POT
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-976
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	43.75 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WHITE WAX (UNII: 7G1J5DA97F)	15.65 mg in 1 g
MINERAL OIL (UNII: T5L8T28FGP)	15.5 mg in 1 g
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)	12 mg in 1 g
LANOLIN (UNII: 7EV65EAW6H)	8 mg in 1 g
3-BROMOCAMPHOR, (+/-)- (UNII: NAY429URSN)	1.7 mg in 1 g
CARNAUBA WAX (UNII: R12CBM0EIZ)	.85 mg in 1 g
COCOA BUTTER (UNII: 512OYT1CRR)	.70 mg in 1 g
MENTHOL (UNII: L7T10EIP3A)	.70 mg in 1 g
2-BUTANOYLOXYBENZOIC ACID (UNII: K60ASJ7Z6N)	.5 mg in 1 g
PHENOL (UNII: 339NCG44TV)	0.4 mg in 1 g

Product Characteristics
Color		Score
Shape		Size
Flavor	MENTHOL	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41520-976-03	1 g in 1 CONTAINER

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	03/12/2013

Labeler - American Sales Company (809183973)

Registrant - American Sales Company (809183973)

Name	Address	ID/FEI	Business Operations
Establishment
OraLabs		801824756	MANUFACTURE(41520-976) , LABEL(41520-976)