Label: AB SKINCARE ACNE SPOT TREATMENT- benzoyl peroxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71563-0400-1 - Packager: Norris Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 27, 2018
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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.
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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
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- ACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AB SKINCARE ACNE SPOT TREATMENT
benzoyl peroxide creamProduct 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)
