SHOPKO MEDICATED LIP TREATMENT- camphor, phenol gel

Shopko Medicated Lip Treatment by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Camphor (1.70%), Menthol (0.70%)

Purpose

Analgesic, Anti-itch

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center right away.

Uses

For the temporary relief of pain and itching associated with fever blisters and cold sores. Helps prevent and temporarily protects dry chapped 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. Keep out of reach of children: if swallowed get medical help or contact a Poison Control Center right away.

Directions

Apply liberally and evenly. Reapply as needed.

Inactive Ingredients

Copernicia Cerifera (Carnauba) Wax, Flavor, Lanolin, Microcrystalline Wax, Mineral Oil, Ozokerite, Petrolatum, Phenol, Salicylic Acid, Theobroma Cacao (Cocoa) Seed Butter.

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

SHOPKO MEDICATED LIP TREATMENT 
camphor, phenol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37012-735
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	1.700 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.700 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP)	1.053 mg  in 1 g
PHENOL (UNII: 339NCG44TV)	0.400 mg  in 1 g
EUCALYPTUS OIL (UNII: 2R04ONI662)	0.500 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U)	83.947 mg  in 1 g
CERESIN (UNII: Q1LS2UJO3A)	1.000 mg  in 1 g
LANOLIN (UNII: 7EV65EAW6H)	8.000 mg  in 1 g

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37012-735-04	1 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	03/15/2013

Labeler - Shopko (023252638)

Registrant - Shopko (023252638)

Establishment
Name	Address	ID/FEI	Business Operations
OraLabs		801824756	MANUFACTURE(37012-735) , LABEL(37012-735)