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Care One Medicated Lip Balm

Medically reviewed on March 12, 2018

Dosage form: stick
Ingredients: PETROLATUM 41mg in 1g
Labeler: American Sales Company
NDC Code: 41520-975

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.

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 MEDICATED LIP BALM 
petrolatum stick
Product Information
Product TypeHUMAN OTC DRUGItem 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 Description
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/FEIOperations
OraLabs801824756MANUFACTURE(41520-975), LABEL(41520-975)

 
American Sales Company

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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