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 Type HUMAN OTC DRUG Item Code (Source) NDC:41520-975
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 41 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CERESIN (UNII: Q1LS2UJO3A) 16 mg  in 1 g
APIS CERANA WORKER SECRETION (UNII: PRG8653U8K) 6 mg  in 1 g
OLEYL ALCOHOL (UNII: 172F2WN8DV) 6 mg  in 1 g
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 5 mg  in 1 g
OCTYLDODECANOL (UNII: 461N1O614Y) 9 mg  in 1 g
LANOLIN (UNII: 7EV65EAW6H) 4 mg  in 1 g
STEARYL ALCOHOL (UNII: 2KR89I4H1Y) 3 mg  in 1 g
CETYL ALCOHOL (UNII: 936JST6JCN) 3 mg  in 1 g
LIGHT MINERAL OIL (UNII: N6K5787QVP) 3 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) .60 mg  in 1 g
Product Characteristics
Color WHITE Score     
Shape Size
Flavor MENTHOL Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41520-975-02 4.25 g in 1 CYLINDER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 03/11/2013
Labeler - American Sales Company (809183973)
Registrant - American Sales Company (809183973)
Establishment
Name Address ID/FEI Business Operations
OraLabs 801824756 MANUFACTURE(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