CARE ONE MEDICATED LIP BALM- petrolatum stick 
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 right away.

Uses

Helps heal severely dry, chapped lips.

Warnings

Stop use and ask a doctor: if rash or irritation develops and lasts.

Directions

Apply to lips not more than 3 – 4 times daily. Children under six months of age: Ask doctor before use.

Inactive Ingredients

Beeswax, Camphor, Cetyl Alcohol, Flavor, Ispropyl Myristate, Lanolin, Menthol, Methylparaben, Mineral Oil, Octyldodecanol, Oleyl Alcohol, Ozokerite, Phenol, Phenyl Trimethicone, Propylparaben, Stearyl Alcohol, Water

Package/Label Principal Display Panel

Care One Lip Balm Card
Care One Lip Balm Label
CARE ONE MEDICATED LIP BALM 
petrolatum stick
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41520-975
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM41 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CERESIN16 mg  in 1 g
APIS CERANA WORKER SECRETION6 mg  in 1 g
OLEYL ALCOHOL6 mg  in 1 g
ISOPROPYL MYRISTATE5 mg  in 1 g
OCTYLDODECANOL9 mg  in 1 g
LANOLIN4 mg  in 1 g
STEARYL ALCOHOL3 mg  in 1 g
CETYL ALCOHOL3 mg  in 1 g
LIGHT MINERAL OIL3 mg  in 1 g
MENTHOL.60 mg  in 1 g
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMENTHOLImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-975-024.25 g in 1 CYLINDER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/11/2013
Labeler - American Sales Company (809183973)
Registrant - American Sales Company (809183973)
Establishment
NameAddressID/FEIBusiness Operations
OraLabs801824756MANUFACTURE(41520-975), LABEL(41520-975)

Revised: 3/2013
Document Id: 448356cb-7794-450b-8810-272489e6981e
Set id: 448356cb-7794-450b-8810-272489e6981e
Version: 1
Effective Time: 20130311
 
American Sales Company