Label: NEUTRACURE RESTORE- benzoyl peroxide cream
- NDC Code(s): 69748-641-01
- Packager: Neutracure
- 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 February 16, 2017
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- Drug Facts
- Active Ingredient
For external use only
When using this product
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with the eyes, lips and mouth
- avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by this product
- with other topical acne medications, at the same time ot immediately following use of this product. Increased dryness or imitation may occur. If this occurs, only one medication should be used unless directed by a doctor.
- skin imitation may occur, characterized by redness, burning, itching, peeling or possibly swelling. More frequent use or higher concentrations may aggravate skin imitation. Mild imitation may be reduced by using the product less frequently or in a lower concentration.
- cleanse the skin thoroughly before applying medication
- cover the entire affected area with a thin layer one to three times a day
- 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 use a sunscreen. Allow Acne Treatment Cream to dry, then follow directions in sunscreen labeling . If sensitivity develops, discontinue use of both products and ask a doctor
- Other Information
ALLANTOIN, ALOE BARBADENSIS LEAF (ALOE VERA GEL) JUICE, BENZYL ALCOHOL, BETULA ALBA (BIRCH) EXTRACT, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, CARBOMER, CITRUS AURANTIUM DULCIS (ORANGE) OIL, CITRUS MEDICA LIMONUM (LEMON) OIL, DMDM HYDANTOIN,
GLYCERIN, HAMAMELIS VIRGINIANA (WITCH HAZEL), IODOPROPYNYL BUTYLCARBAMATE, MELALEUCA ALTERNIFOLIA (TEA TREE) OIL, MENTHOL,
METHYLISOTHIAZOLINONE, PARFUM (FRAGRANCE), POLYSORBATE-20, SACCHARUM OFFICINALIS (SUGAR) CANE EXTRACT, SALIX ALBA (WILLOW) BARK EXTRACT, SALVIA OFFICINALIS (SAGE) EXTRACT, SODIUM CITRATE, SODIUM HYALURONATE (HYALURONIC ACID), SODIUM HYDROXIDE,
TRIETHANOLAMINE, VACCINIUM MYRTILLUS (BILBERRY) EXTRACT, XANTHAN GUM
- Product Label
INGREDIENTS AND APPEARANCE
benzoyl peroxide cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69748-641 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 ALLANTOIN (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) BENZYL ALCOHOL (UNII: LKG8494WBH) ORANGE OIL (UNII: AKN3KSD11B) DMDM HYDANTOIN (UNII: BYR0546TOW) GLYCERIN (UNII: PDC6A3C0OX) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) MENTHOL (UNII: L7T10EIP3A) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) POLYSORBATE 20 (UNII: 7T1F30V5YH) SALIX ALBA BARK (UNII: 205MXS71H7) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM HYDROXIDE (UNII: 55X04QC32I) TROLAMINE (UNII: 9O3K93S3TK) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69748-641-01 59 mL in 1 JAR; Type 0: Not a Combination Product 02/07/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 04/10/2015 Labeler - Neutracure (079725043)