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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41520-976
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM43.75 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WHITE WAX15.65 mg  in 1 g
MINERAL OIL15.5 mg  in 1 g
MICROCRYSTALLINE WAX12 mg  in 1 g
LANOLIN8 mg  in 1 g
3-BROMOCAMPHOR, (+/-)-1.7 mg  in 1 g
CARNAUBA WAX.85 mg  in 1 g
COCOA BUTTER.70 mg  in 1 g
MENTHOL.70 mg  in 1 g
2-BUTANOYLOXYBENZOIC ACID.5 mg  in 1 g
PHENOL0.4 mg  in 1 g
Product Characteristics
Color    Score    
ShapeSize
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-976-031 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/12/2013
Labeler - American Sales Company (809183973)
Registrant - American Sales Company (809183973)
Establishment
NameAddressID/FEIBusiness Operations
OraLabs801824756MANUFACTURE(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