Label: DERMACLEAR SPOT TREATMENT- benzoyl peroxide cream
- NDC Code(s): 62742-4075-3, 62742-4075-4
- 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 December 2, 2020
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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WHEN USING
When using this product:
- Avoid contact with the eyes, lips, and mouth
- Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
- If sensitive to the sun or when increased sun exposure is expected use a sunscreen.
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive Ingredients:
Water ( Aqua),Propylene Glycol, Glycerin, Sorbitol, Dimethyl Sulfone, PEG-8/SMDI Copolymer, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Carbomer, Triethanolamine, Collidal Silver, Salix Alba (Willow) Bark Extract, Malva Sylvestns (Mallow) Extract, Mentha Pipenta (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Millefolium Extract, Melia Azadirachta Leaf Extract, Butylene Glycol, PEG-60 Almond Glycerides, Nordihydroguaiaretic Acid, Oleanolic Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Leptospermum Scoparium Branch/ Leaf Oil, Enantia Chlorantha Bark Extract, Maltodextrin, Syringa Vulgaris (Lilac) Leaf Cell Culture Extract, Disodium EDTA
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DERMACLEAR SPOT TREATMENT
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4075 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength HEXYLENE GLYCOL (UNII: KEH0A3F75J) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) AZADIRACHTA INDICA LEAF (UNII: HKY915780T) ALCHEMILLA XANTHOCHLORA FLOWERING TOP (UNII: 9M289NKI69) VERONICA OFFICINALIS FLOWERING TOP (UNII: 9IH82J936J) ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F) MASOPROCOL (UNII: 7BO8G1BYQU) TEA TREE OIL (UNII: VIF565UC2G) MANUKA OIL (UNII: M6QU9ZUH2X) OLEANOLIC ACID (UNII: 6SMK8R7TGJ) ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) PEG-8/SMDI COPOLYMER (UNII: CCX72L6NY6) SALIX ALBA BARK (UNII: 205MXS71H7) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) TROLAMINE (UNII: 9O3K93S3TK) SILVER (UNII: 3M4G523W1G) MALTODEXTRIN (UNII: 7CVR7L4A2D) EDETATE DISODIUM (UNII: 7FLD91C86K) MENTHA PIPERITA LEAF (UNII: A389O33LX6) PRIMULA VERIS (UNII: W6LFQ57E4M) SYRINGA VULGARIS WHOLE (UNII: U49SHU1VCI) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62742-4075-4 1 in 1 CARTON 05/05/2015 1 NDC:62742-4075-3 4.8 g in 1 BOTTLE, WITH APPLICATOR; 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 05/05/2015 Labeler - Allure Labs Inc (926831603) Registrant - Allure Labs Inc (926831603) Establishment Name Address ID/FEI Business Operations Allure Labs Inc 926831603 manufacture(62742-4075)
