Label: HUMANE ACNE SPOT TREATMENT- benzoyl peroxide gel
- NDC Code(s): 73010-127-00
- Packager: Apprendista, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 11, 2023
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- Drug Facts
- Active ingredient
- Use
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Warnings
For external use only.
When using this product
- Skin irritation and dryness are 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 unnecessary sun exposure and use a sunscreen.
- Avoid contact with eyes, lips and mouth. Avoid product 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.
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Directions
- 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 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.
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Inactive ingredients
a-Bisabalol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Caprylyl Glycol, Cucumis Sativus (Cucumber) Extract, Glycyrrhiza Glabra (Licorice) Extract, Hexylene Glycol, Menthyl Lactate, Phenoxyethanol, Polysorbate-20, Potassium Sorbate, Propylene Glycol, Sodium Hydroxide
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INGREDIENTS AND APPEARANCE
HUMANE ACNE SPOT TREATMENT
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73010-127 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ALLANTOIN (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CUCUMBER (UNII: YY7C30VXJT) LICORICE (UNII: 61ZBX54883) HEXYLENE GLYCOL (UNII: KEH0A3F75J) MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73010-127-00 1 in 1 BOX 03/01/2021 1 30 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 Drug M006 03/01/2021 Labeler - Apprendista, LLC (116995922)