AB SKINCARE ACNE SPOT TREATMENT- benzoyl peroxide cream 
Norris Ltd

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.

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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.

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.

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

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.

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

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

For the treatment of acne

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

Benzoyll Peroxide 10%

TUBE LABEL CARTON LABEL

AB SKINCARE ACNE SPOT TREATMENT 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71563-0400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE28.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71563-0400-128 g in 1 TUBE; Type 0: Not a Combination Product10/09/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D10/09/2017
Labeler - Norris Ltd (061314247)

Revised: 9/2018
Document Id: 76df73c6-0daf-fc83-e053-2991aa0a2b0e
Set id: 5437ccae-587a-6be4-e054-00144ff88e88
Version: 2
Effective Time: 20180927
 
Norris Ltd