SHOPKO MEDICATED LIP BALM- petrolatum stick
Shopko

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, contact a Poison Control Center.

Uses

Helps prevent and temporarily protects chapped or windburned lips.

Warnings

For external use only.

When using this product: avoid contact with eyes. Rinse with water to remove. Stop use and ask a doctor if :rash or irritation develops and lasts for more than 7 days. .

Directions

Apply liberally and evenly as needed. Children under 2 years 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

SHOPKO MEDICATED LIP BALM
petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37012-737
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	41 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:37012-737-02	4.25 g in 1 CYLINDER

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	03/11/2013

Labeler - Shopko (023252638)

Registrant - Shopko (023252638)

Name	Address	ID/FEI	Business Operations
Establishment
OraLabs		801824756	MANUFACTURE(37012-737) , LABEL(37012-737)