Label: HEALTHY SKIN MOISTURIZER- benzoyl peroxide moisturizer lotion

  • 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 March 26, 2020

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  • Drug Facts

    Active Ingredient               Purpose

    Benzoyl Peroxide 2.5%.........Acne Treatment

  • PURPOSE

    Use

    • For the treatment of acne.
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • If you are sensitive to Benzoyl Peroxide or have very sensitive skin.  This product may cause irritation.
    • If you are pregnant or breast feeding.
  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use

    • If you are using other topical ance drugs at the same time or right after use of this product.  This may increase dryness, redness, or irritation of the skin.  If this occurs, only one medication should be used unless a doctor directs otherwise.
  • INDICATIONS & USAGE

    When using this product

    • Avoid contact with eyes.  If contact occurs, flush thoroughly with water.  Keep away from lips and mouth.
    • Avoid unneccesary sun exposure and use a sunscreen.
    • Avoid product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.
  • STOP USE

    Stop use and ask a doctor

    • If excessive 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

    • Use every morning and evening.  Apply to entire face, avoiding the eye area.  Do not rinse.  If peeling occurs, reduce application use.  May also be used on chest and back.
  • INACTIVE INGREDIENT

    Inactive Ingredients  .Alpha.Tocopherol, DL-, Actinidia Chinensis (Kiwi) Fruit Extract, Aminomethylproanol, Cannabis Sativa Seed Oil, Caprylyl Glycol, Cetyl Alcohol, Citrullus Lanatis (Watermelon) Fruit Extract, Ethylhexylglycerin, Glycerin, Glyceryl Monostearate, Isopropyl Palmitate, Lens Esculenta (Lentil) Fruit Extract, Medium-Chain Triglycerides, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Pyrus Malus (Apple) Fruit Extract, Sodium Lactate, Sodium Pyrrolidone Carboxylate, Sorbic Acid, Stearic Acid, Water, Xanthan Gum

  • QUESTIONS

    Questions?  Hello@healthyskincbd.com

  • PRINCIPAL DISPLAY PANEL

    Healthyskin Moisturizer 1ozHealthyskin Moisturizer 1oz

  • PRINCIPAL DISPLAY PANEL

    Healthysking SleeveHealthysking Sleeve

  • INGREDIENTS AND APPEARANCE
    HEALTHY SKIN MOISTURIZER 
    benzoyl peroxide moisturizer lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-3801
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE0.0625 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    WATER (UNII: 059QF0KO0R)  
    WATERMELON (UNII: 231473QB6R)  
    APPLE (UNII: B423VGH5S9)  
    LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    KIWI FRUIT (UNII: 71ES77LGJC)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52261-3801-10.0357 kg in 1 TUBE; Type 0: Not a Combination Product01/25/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/25/2019
    Labeler - Cosco International, Inc. (016433141)
    Registrant - Cosco International, Inc. (016433141)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture(52261-3801) , label(52261-3801) , pack(52261-3801)
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