Label: 24 HOUR ACNE SERUM- benzoyl peroxide gel
- NDC Code(s): 39765-034-01
- Packager: Neutraderm, Inc.
- 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 June 7, 2019
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- Drug Facts
- Active ingredient
- Purpose
- Use
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Warnings
For external use only.
When using this product • avoid unnecessary sun exposure and use sunscreen. • avoid contact with eyes, lips and mouth. • avoid contact with hair and dyed products, 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. Apply affected area with a thin layer, avoiding eye area. Allow to absorb before applying additional products. Can be used twice daily or as directed by physician. If irritation or sensitivity develops, stop use of product and consult physician.
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Inactive Ingredients
Water, Glycolic Acid, Sclerotium Gum, Arnica Montana Flower Extract, Allantoin, Echinacea Purpurea Extract, Hydrastis Canadensis (Goldenseal) Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Calendula Officinalis Flower Extract, Glycerin, Gluconolactone, Sodium Benzoate, Tetrasodium EDTA, Sodium Hydroxide
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- Packaging
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INGREDIENTS AND APPEARANCE
24 HOUR ACNE SERUM
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:39765-034 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 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCOLIC ACID (UNII: 0WT12SX38S) BETASIZOFIRAN (UNII: 2X51AD1X3T) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) ALLANTOIN (UNII: 344S277G0Z) ECHINACEA PURPUREA (UNII: QI7G114Y98) GOLDENSEAL (UNII: ZW3Z11D0JV) LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) GLYCERIN (UNII: PDC6A3C0OX) GLUCONOLACTONE (UNII: WQ29KQ9POT) SODIUM BENZOATE (UNII: OJ245FE5EU) EDETATE SODIUM (UNII: MP1J8420LU) SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics Color white (White to Off White) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:39765-034-01 32 g in 1 BOTTLE; Type 0: Not a Combination Product 02/08/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 02/08/2019 Labeler - Neutraderm, Inc. (146224444) Establishment Name Address ID/FEI Business Operations Neutraderm, Inc. 146224444 manufacture(39765-034)
