ACNE SPOT TREATMENT- benzoyl peroxide 10% cream

Acne Spot Treatment by

Drug Labeling and Warnings

Acne Spot Treatment by is a Otc medication manufactured, distributed, or labeled by CVS, Product Quest Mfg, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzoyl Peroxide 10%

Purpose

Acne treatment

Uses

For the treatment of acne.

Warnings

For external use only.

Do not use

• if you have very sensitive skin or are sensitive to Benzoyl Peroxide

When using this product

• 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.
• rinse right away with water if it gets in eyes.
• avoid unnecessary sun exposure and use a sunscreen.
• avoid contact with eyes, lips, and mouth.
• avoid contact with hair and dyed fabrics, which may be bleached by this product.
• skin irritation may occur, characterized by redness, burning, itching, peeling, possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop and ask a doctor if

• irritation becomes severe

Keep out of reach of children

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

Directions

• cleanse the skin thoroughly before applying medication
• cover the entire affected area with a thin layer one to three times a day
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 to 3 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, use a sunscreen. Allow product to dry then follow directions in the sunscreen labeling. if sensitivity develops, discontinue use of both products and cpnsult a doctor.

Inactive ingredients

Aluminum hydroxide, Bentonite, Carbomer, Glyceryl Stearate SE, Isopropyl myristate, Methylparaben, PEG-12, Potassium Hydroxide, Propylene Glycol, Propylparaben, Water

PRINCIPAL DISPLAY PANEL

CVS Acne Spot Treatment

Maximum Strength

10% Benzoyl Peroxide

INGREDIENTS AND APPEARANCE

ACNE SPOT TREATMENT 
benzoyl peroxide 10% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-243
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BENTONITE (UNII: A3N5ZCN45C)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-243-01	1 in 1 CARTON	10/31/2014
1		28 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	10/31/2014

Labeler - CVS (062312574)

Registrant - Product Quest Mfg, LLC (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg, LLC		927768135	manufacture(59779-243) , label(59779-243)