Label: DERMAWASH S2- sulfur soap soap

  • 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 October 20, 2020

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  • Dosage & Administration

    Directions for Use:
    1. Rinse face and/or body with warm water.
    2. Dispense 1 to 2 pumps of cleanser onto palm or washcloth.
    3. Rub palms or washcloth together, spreading cleanser evenly and building a lather.
    4. Cleanse skin gently but thoroughly.
    5. Rinse face and/or body with warm water.

  • Purpose

    Designed for daily use, KAVI DermaWash S2 provides an ideal approach to cleansing oily or combination skin. DermaWash S2 utilizes allergy-tested ingredients that are non-comedogenic, pH-balancing, and completely free of animal products.

    With the same dosage of sulfur as Coral KAVI, DermaWash S2 is best suited for the treatment of acne-prone skin.
    DermaWash S2 can be also used in preparation of the skin prior to administration of a KAVI chemical peel.

  • Indications & Usage

    DermaWash S2 is best suited for the treatment of acne-prone skin.

    Directions:
    1. Rinse face and/or body with warm water.
    2. Dispense 1 to 2 pumps of cleanser onto palm or washcloth.
    3. Rub palms or washcloth together, spreading cleanser evenly and building a lather.
    4. Cleanse skin gently but thoroughly.
    5. Rinse face and/or body with warm water.

  • Active Ingredients

    Active Ingredient: colloidal sulfur (2%)

  • Inactive Ingredients

    Inactive Ingredients: purified water, lauric acid, acrylates copolymer, cocamidopropyl betaine, potassium hydroxide, myristic acid, glycerin, ethylene glycol distearate, olive oil PEG-7 ester, hamamelis virginiana extract, polyquaternium-7, sodium laureth sulfate, DMDM tocopherol acetate, butyl hydroxy toluene, disodium EDTA, light fragrance.

  • Warnings

    For external use only. If swallowed, seek medical attention. Avoid contact with eyes and mucous membranes. In case of eye contact, flush with cold water. Keep out of reach of children.

  • Keep out of reach of children

    CAUTION: For external use only. If swallowed, seek medical attention. Avoid contact with eyes and mucous membranes. In case of eye contact, flush with cold water. Keep out of reach of children.

  • Front and Back Labels

    label front and back

    Designed for daily use, KAVI DermaWash S2 provides an ideal approach to cleansing oily or combination skin. DermaWash S2 utilizes allergy-tested ingredients that are non-comedogenic, pH-balancing, and completely free of animal products.
    With the same dosage of sulfur as Coral KAVI, DermaWash S2 is best suited for the treatment of acne-prone skin.
    DermaWash S2 can be also used in preparation of the skin prior to administration of a KAVI chemical peel.

    DermaWash S2 is made with colloidal sulfur to enhance the hydrolipidic layer’s acidity and protect skin from bacterial infections. Suitable for use on the face and body, it is easy on the senses and a practical replacement to traditional animal-based soaps.

    Directions:
    1. Rinse face and/or body with warm water.
    2. Dispense 1 to 2 pumps of cleanser onto palm or washcloth.
    3. Rub palms or washcloth together, spreading cleanser evenly and building a lather.
    4. Cleanse skin gently but thoroughly.
    5. Rinse face and/or body with warm water.

    Active Ingredient: colloidal sulfur (2%). Inactive Ingredients: purified water, lauric acid, acrylates copolymer, cocamidopropyl betaine, potassium hydroxide, myristic acid, glycerin, ethylene glycol distearate, olive oil PEG-7 ester, hamamelis virginiana extract, polyquaternium-7, sodium laureth sulfate, DMDM tocopherol acetate, butyl hydroxy toluene, disodium EDTA, light fragrance.

    CAUTION: For external use only. If swallowed, seek medical attention. Avoid contact with eyes and mucous membranes. In case of eye contact, flush with cold water. Keep out of reach of children.

  • INGREDIENTS AND APPEARANCE
    DERMAWASH S2 
    sulfur soap soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42771-0036
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK) 7 g  in 100 g
    GLYCOL DISTEARATE (UNII: 13W7MDN21W) 3 g  in 100 g
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 3 g  in 100 g
    MYRISTIC ACID (UNII: 0I3V7S25AW) 2 g  in 100 g
    LAURYL BETAINE (UNII: Y4P927Q133) 2 g  in 100 g
    WATER (UNII: 059QF0KO0R) 57.75 g  in 100 g
    SODIUM LAURYL SULFATE (UNII: 368GB5141J) 10 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42771-0036-11 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H03/01/2007
    Labeler - KAVI Skin Solutions, Inc. (179144683)