FACE VALUES ACNE MEDICATION- benzoyl peroxide gel

FACE VALUES ACNE MEDICATION by

Drug Labeling and Warnings

FACE VALUES ACNE MEDICATION by is a Otc medication manufactured, distributed, or labeled by HARMON STORES, INC., FRUIT OF THE EARTH, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzoyl Peroxide 10%

Purpose

Acne Medication

Uses

for the treatment of acne

Warnings

For external use only

DO NOT USE

Do not use if you  have very sensitive skin  are sensitive to benzoyl peroxide 

When using this product

• avoid contact with the eyes, lips, and mouth
• avoid unnecessary sun exposure and use a sunscreen
• avoid contact with hair and dyed fabrics which may be bleached by this product
• skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
• skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

ASK DOCTOR

Stop use and ask a doctor if  irritation becomes severe

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Clean the skin thoroughly before applying this product
• Cover the entire affected area with a thin layer one to three times daily
• Becasue excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day
• If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Inactive ingredients

carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, water

PRINCIPAL DISPLAY PANEL

FACE VALUES ACNE MEDICATION 10% BENZOYL PEROXIDE GEL

1 OZ (28.3g)

NDC: 63940-063-16

FACE VALUES ACNE MEDICATION 10% BENZOYL PEROXIDE GEL

BLISTER PACK

NDC: 63940-063-17

INGREDIENTS AND APPEARANCE

FACE VALUES ACNE MEDICATION 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63940-063
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35)
LAURETH-4 (UNII: 6HQ855798J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63940-063-17	1 in 1 CARTON	11/15/2010
1	NDC: 63940-063-16	28.3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	11/15/2010

Labeler - HARMON STORES, INC. (804085293)

Registrant - FRUIT OF THE EARTH, INC. (079559467)

Establishment
Name	Address	ID/FEI	Business Operations
FRUIT OF THE EARTH, INC.		008193513	manufacture(63940-063)