Label: DERMATOLOGICAL- butylated hydroxytoluene soap

  • NDC Code(s): 79577-7000-1
  • Packager: PROMAQUILA DE COCULA, S.A. DE C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 May 29, 2023

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  • ACTIVE INGREDIENT SECTION

    ACTIVE INGREDIENT Butylhydroxytoluene (BHT) .10 %

    ALCOHOL

  • PURPOSE

    PURPOSE ANTIFUNGAL

  • DOSAGE AND ADMINISTRATION

    DIRECTIONS

    Wet your hands with clean water take the bar of soap and foam it. Thoroughly rub your hands between fingers all inside and outside surfaces,nails. Rinse your hands with clean water.

  • WARNINGS

    WARNING

    FOR EXTERNAL USE ONLY

  • WARNINGS AND PRECAUTIONS

    WARNINGS AND PRECAUTIONS

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • STOP USE SECTION

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • USE

    Use[s]

    For washing to decrease bacteria and fungus on skin

  • INACTIVE INGREDIENTS

    INACTIVE INGREDIENTS

    Soap base paste (Sodium Tallowate, Beef, Sodium Cocoate)
    Sodium laureth-3 sulfate

    Pomegranate & Sunflower Fragrance

    Calendula Officinalis Flower
    Edetic Acid

  • WARNING SECTION

    For external use only.

  • PRINCIPAL DISPLAY PANEL

    DERMATOLOGICAL SOAP 125 FINAL

  • INGREDIENTS AND APPEARANCE
    DERMATOLOGICAL 
    butylated hydroxytoluene soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79577-7000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.001 g  in 1 g
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) (BUTYLATED HYDROXYTOLUENE - UNII:1P9D0Z171K) BUTYLATED HYDROXYTOLUENE0.001 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETIC ACID (UNII: 9G34HU7RV0) 0.001 g  in 1 g
    SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW) 0.8622 g  in 1 g
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) 0.1 g  in 1 g
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) 0.194 g  in 1 g
    SODIUM COCOATE (UNII: R1TQH25F4I) 0.0957 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79577-7000-1125 g in 1 POUCH; Type 0: Not a Combination Product05/04/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/04/2023
    Labeler - PROMAQUILA DE COCULA, S.A. DE C.V. (812760470)
    Registrant - PROMAQUILA DE COCULA, S.A. DE C.V. (812760470)
    Establishment
    NameAddressID/FEIBusiness Operations
    PROMAQUILA DE COCULA, S.A. DE C.V.812760470manufacture(79577-7000)
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