SHOPKO MEDICATED LIP TREATMENT- camphor, phenol gel
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

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

Front and Back of Card - Shopko Lip Treatment

SHOPKO MEDICATED LIP TREATMENT
camphor, phenol gel

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - Shopko (023252638)

Registrant - Shopko (023252638)

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