Label: DERMAWASH S2- sulfur soap soap
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Contains inactivated NDC Code(s)
NDC Code(s): 42771-0036-1 - Packager: KAVI Skin Solutions, Inc.
- 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
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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
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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
- Keep out of reach of children
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Front and Back Labels
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.
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INGREDIENTS AND APPEARANCE
DERMAWASH S2
sulfur soap soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42771-0036 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 2 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:42771-0036-1 1 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358H 03/01/2007 Labeler - KAVI Skin Solutions, Inc. (179144683)