Label: DERMACLEAR PURITY CLEANSER LEVEL I- benzoyl peroxide gel
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Contains inactivated NDC Code(s)
NDC Code(s): 62742-4092-1, 62742-4092-2 - Packager: Allure Labs, 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 November 28, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Other Ingredients: Water (Aqua), Sorbitol, Cetyl Alcohol, Stearyl Alcohol, Propylene Glycol, Glycerin, Ammonium Lauryl Sulfate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Dimethyl Sulfone, PPG-12/SMDI Copolymer, Disodium EDTA, Melia Azadirechta Leaf Extract, Silver, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Salix Alba (Willow) Bark Extract, Malva Sylvestris (Mallow) Extract, Mentha Piperita (Peppermint) Leaf Extract, Achillea Millefoluium Extract, Butylene Glycol, PEG-60 Almond Glycerides, Carbomer, Nordihydroguaiaretic Acid, Oleanolic Acid, Leptospermum Scoparium Branch/Leaf Oil.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DERMACLEAR PURITY CLEANSER LEVEL I
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4092 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 25 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) CETYL ALCOHOL (UNII: 936JST6JCN) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E) EDETATE DISODIUM (UNII: 7FLD91C86K) AZADIRACHTA INDICA LEAF (UNII: HKY915780T) SILVER (UNII: 3M4G523W1G) TEA TREE OIL (UNII: VIF565UC2G) SALIX ALBA BARK (UNII: 205MXS71H7) MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J) MENTHA PIPERITA LEAF (UNII: A389O33LX6) PRIMULA VERIS (UNII: W6LFQ57E4M) ALCHEMILLA XANTHOCHLORA FLOWERING TOP (UNII: 9M289NKI69) VERONICA OFFICINALIS FLOWERING TOP (UNII: 9IH82J936J) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) NORDIHYDROGUAIARETIC ACID, (+/-)- (UNII: 7PZ73W4ZNR) OLEANOLIC ACID (UNII: 6SMK8R7TGJ) LEPTOSPERMUM SCOPARIUM LEAF (UNII: V3FJ3507Y9) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4092-2 1 in 1 CARTON 12/01/2017 1 NDC:62742-4092-1 177.4 mL in 1 BOTTLE; 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 11/28/2017 Labeler - Allure Labs, Inc. (926831603)