CHAPICE MEDICATED BALM- camphor, menthol gel

ChapIce Medicated Balm by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Camphor (1.7%), Menthol (0.7%)

Purpose

External Analgesic, External Analgesic

Keep Out of Reach of Children

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

Uses

Helps to provide relief of the symptoms of cold sores and dry chapped lips.

Warnings

For external use only. When using this product: avoid contact with eyes. Stop use and ask a doctor if irritation and rash occur.

Directions

Apply freely to affected area. Consult a physician for use on children under 2 years of age.

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

CHAPICE MEDICATED BALM 
camphor, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63645-161
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: 63645-161-04	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 - OraLabs (801824756)

Registrant - OraLabs (801824756)

Establishment
Name	Address	ID/FEI	Business Operations
OraLabs		801824756	MANUFACTURE(63645-161) , LABEL(63645-161)