SHOPKO MEDICATED LIP BALM- petrolatum stick

Shopko Medicated Lip Balm by

Drug Labeling and Warnings

Shopko Medicated Lip Balm by is a Otc medication manufactured, distributed, or labeled by Shopko, OraLabs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SHOPKO MEDICATED LIP BALM 
petrolatum stick

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

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: 37012-737-02	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 - Shopko (023252638)

Registrant - Shopko (023252638)

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