Label: ADVANCED ACNE WASH- benzoyl peroxide liquid, extended release
- 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.
Updated October 8, 2015
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Do not use if you
When using this product
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, or possibly swelling. Irritation may be reduced by using the product less frequently.
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.
- Stop use and ask a doctor if
- Keep out of reach of children
Apply to hands then work into a lather and massage gently onto face
Rinse thoroughly and pat dry
Because excessive drying of the skin may occur, start with one application daily, then increase to 2 times daily if needed or as directed by a doctor
If bothersome dryness or peeling occurs, reduce usage to 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 ask a doctor.
- Other information
- Inactive ingredients
- Advanced Acne Wash
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ADVANCED ACNE WASH
benzoyl peroxide liquid, extended release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42783-635 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 44 mg in 1 mL Inactive Ingredients Ingredient Name Strength SHEA BUTTER (UNII: K49155WL9Y) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CANDELILLA WAX (UNII: WL0328HX19) HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH) LAURETH-7 (UNII: Z95S6G8201) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42783-635-04 104 mL 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 09/17/2015 Labeler - Elorac, Inc. (832590009) Registrant - Elorac, Inc. (832590009)