Label: DERMACLEAR PURITY CLEANSER LEVEL I- benzoyl peroxide gel

  • 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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  • ACTIVE INGREDIENT

    Active Ingredient: Benzoyl Peroxide - 2.5%

  • PURPOSE

    Purpose: Anti-acne

  • INDICATIONS & USAGE

    Uses:

    For the treatment and management of mild acne.

  • WARNINGS

    Warnings:

    For external use only.

  • DO NOT USE

    Do not use if you:

    • Have any sensitive skin.
    • Are sensitive to benzoyl peroxide.
  • WHEN USING

    When using this product:

    • Avoid contact with eyes, lips and mouth.
    • Avoid contact with hair and dyed fabric, which may be bleached by this product.
  • STOP USE

    Stop use and ask a doctor - if severe skin irritation occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Emulsify cleanser with lukewarm water and gently massage onto the skin.
    • Rinse well and pat dry.
    • Not recommended for those with nut allergies.
  • 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

    Manufactured for DermaQuest, Inc.

    Hayward, CA 94544

    1272 GK, NL Made in USA

    dermaquestinc.com

    Image PurCl-1 60

  • INGREDIENTS AND APPEARANCE
    DERMACLEAR PURITY CLEANSER LEVEL I 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4092
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4092-21 in 1 CARTON12/01/2017
    1NDC:62742-4092-1177.4 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/28/2017
    Labeler - Allure Labs, Inc. (926831603)
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