Label: DERMAD ANTIFUNGAL THERAPEUTIC- salicylic acid cream

  • 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 9, 2021

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  • Active Ingredient

    Salicylic Acid....2%

  • Purpose

    Fungus treatment

  • Uses

    Relieves and helps prevent

    • itching
    • irritation
    • redness due to jock itch
  • Warnings

    For external use only

    When using this product

    avoid contact with eyes. If contact occurs, rinse eyes thoroughly with lukewarm water.

    Keep out of reach of children

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

  • Directions

    • Apply to the affected area one to three times a day or as directed by a doctor.
    • Apply on clean and dry skin in circular motion.
    • To avoid running or dripping, lightly squeeze the tube.
  • Other Information

    Store between 63°/80°F (17-30C)

    Protect from humidity.

  • Inactive Ingredients

    water, mineral oil, gms-se, Cetyl alcohol, cera alba, sweet almond oil, simmondsia chinensis seed oil, vitis vinifera seed oil, decyl oleate, coconut oil, brij-72, Trictum vulgaris (wheat) germ oil, butyrospermum parkii (shea) butter, brij-721, phenoxyethanol, triethylene glycol, Xanthan gum, BHT, Tocopheryl Acetate, Cannabis Sativa Seed Oil, farnesol

  • Principal Display Panel

    NDC 70794-708-85

    DERMAD ANTIFUNGAL Therapeutic Cream

    RELIEVES

    • IRRITATION
    • ITCHING
    • REDNESS

    FDA REGISTERED

    DOES NOT CONTAIN STEROIDS, CORTISONE, FRAGRANCES AND COLORING

    2.75 FL. OZ (81 mL)

    pic

  • INGREDIENTS AND APPEARANCE
    DERMAD ANTIFUNGAL THERAPEUTIC 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70794-708
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    DECYL OLEATE (UNII: ZGR06DO97T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TRIETHYLENE GLYCOL (UNII: 3P5SU53360)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    FARNESOL (UNII: EB41QIU6JL)  
    CANNABIS SATIVA SEED (UNII: QE567Z26NG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70794-708-8581 g in 1 TUBE; Type 0: Not a Combination Product07/08/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B07/08/2021
    Labeler - Chen Cohen Industries Inc. (080534875)
    Registrant - Chen Cohen Industries Inc. (080534875)
    Establishment
    NameAddressID/FEIBusiness Operations
    Peer Pharm Ltd.514678390manufacture(70794-708)
    Establishment
    NameAddressID/FEIBusiness Operations
    Emilia Cosmetics Ltd600076624manufacture(70794-708)
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