Label: HYR ACNE WASH- benzoyl peroxide solution
- NDC Code(s): 70481-330-06, 70481-330-12
- Packager: General Resources LLC
- 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 18, 2020
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
For external use only.
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 or in a lower concentration
- 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.
DOSAGE & ADMINISTRATION
- shake well
- wet affected area and apply product in a thin layer one to three times daily. Rinse well and pat dry.
- 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 directed by a doctor.
- if bothersome dryness or peeling occurs, reduce application to once a day or every other day
- if going outside, use a sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
HYR ACNE WASH
benzoyl peroxide solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70481-330 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARIC ACID (UNII: 4ELV7Z65AP) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70481-330-06 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 10/19/2020 2 NDC:70481-330-12 120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 10/19/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 10/19/2020 Labeler - General Resources LLC (117648210)