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 Pot Card
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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 43.75 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
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     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-976-03 1 g in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 03/12/2013
Labeler - American Sales Company (809183973)
Registrant - American Sales Company (809183973)
Establishment
Name Address ID/FEI Business Operations
OraLabs 801824756 MANUFACTURE(41520-976) , LABEL(41520-976)

Revised: 3/2013
Document Id: 0c9d4c39-a4ba-41d6-80f5-93bf38961de4
Set id: 0c9d4c39-a4ba-41d6-80f5-93bf38961de4
Version: 1
Effective Time: 20130311
 
American Sales Company