AB SKINCARE ACNE SPOT TREATMENT- benzoyl peroxide cream

AB Skincare Acne Spot Treatment by

Drug Labeling and Warnings

AB Skincare Acne Spot Treatment by is a Otc medication manufactured, distributed, or labeled by Norris Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

For external use ONLY. 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. Avoid unnessary sun exposure and use a sunscreen. Avoid contact with eyes, lips and mouth. Avoid contact with hair, 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 lower concentration.

DO NOT USE If you have very sensitive skin or are sensitive to Benzoyl Peroxide. STOP USE AND ASK DOCTOR if irritation becomes severe.

INSTRUCTIONS FOR USE

Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily. Because 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 nto 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 and ask a doctor.

GERIATRIC USE

Keep tightly closed and protect product from freezing or becoming excessively hot. Please refer any questions to 503.887.7087 or www.abskincare.com

DOSAGE & ADMINISTRATION

One application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness occurs, reduce daily aplication to once a day or every other day.

INACTIVE INGREDIENT

Water, carbomer, Sodium Dioctyl Sulfosuccinate, Tetrasodium Glutamate Diacetate, Propylene Glycol, Sodium Citrate, Dimethicone, PEG_40, Silica, Sorbitan Stearate, Xanthan Gum

INDICATIONS & USAGE

If irritation or sensitivy develops stop use of both products and ask a doctor

PURPOSE

For the treatment of acne

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.

ACTIVE INGREDIENT

Benzoyll Peroxide 10%

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AB SKINCARE ACNE SPOT TREATMENT 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71563-0400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	28.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
METHOXY PEG-40 (UNII: 6AXS45P1QU)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
WATER (UNII: 059QF0KO0R)
DIMETHICONE 1000 (UNII: MCU2324216)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
2-PHENYLPROPANAL PROPYLENE GLYCOL ACETAL (UNII: 1ZRR9A405A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71563-0400-1	28 g in 1 TUBE; Type 0: Not a Combination Product	10/09/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	10/09/2017

Labeler - Norris Ltd (061314247)