DR ACNE WASH FACIAL CLEANSER- benzoyl peroxide cream

Dr Acne Wash Facial Cleanser by

Drug Labeling and Warnings

Dr Acne Wash Facial Cleanser by is a Otc medication manufactured, distributed, or labeled by Clinical Resolution Laboratory, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredient

Benzoyl Peroxide 10%

Purpose

Acne Treatment

Uses:

for the treatment of acne.

Warnings

For external use only

Do not use

• if you are sentitive to Benzoyl Peroxide or have very sensitive skin.
• using other topical acne drugs at the same time or right after use of this product may increase dryness, redness or irritation of the skin.
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

When using this product

• avoid contact with and near eyes. If contact occurs, flush thoroughly with water.
• keep away from lips and mouth.
• avoid unnecessary sun exposure and use a sunscreen.
• avoid product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.

Stop use and ask doctor if

irritation becomes severe and continues

Keep out of reach of children

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

Other information

Keep tightly closed when not in used. Store at room temperature 20°- 30°C (68°- 86°F)

Directions

Apply a dime to quarter-sized amount and gently massage into damp skin, avoiding area near eyes. Wait 1~2 minutes (If can be tolerated, then 3~5 minutes) to allow wash to absorb, then rinse thoroughly with warm water. Follow with oil free moisturizer over skin to nourish and rehydrate and to soothe irritation and prevent flakiness. Apply at least SPF 30 sunscreen if going outside.

Inactive ingredients

Cannabis Sativa (Hemp) Seed Oil, Carbomer, Centella Asiatica Extract, Cocamidopropyl Betaine, Dimethyl Isosorbide, Fragrance, Glycerin, Isododecane, Melaleuca Alternafolia (Tea Tree) Leaf Oil, Phenoxyethanol, Purified Water, Sodium Benzoate, Sodium Hydroxide

Package Labeling:

INGREDIENTS AND APPEARANCE

DR ACNE WASH FACIAL CLEANSER 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63742-020
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 mL

Inactive Ingredients
Ingredient Name	Strength
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63742-020-00	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	02/15/2019

Labeler - Clinical Resolution Laboratory, Inc. (825047942)

Establishment
Name	Address	ID/FEI	Business Operations
Clinical Resolution Laboratory, Inc.		825047942	manufacture(63742-020) , label(63742-020) , pack(63742-020)