Label: DERMAWASH- sulfur soap soap
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Contains inactivated NDC Code(s)
NDC Code(s): 42771-0035-1 - 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
KAVI DermaWash provides an ideal approach to cleansing normal or combination skin with pH sensitivity. DermaWash utilizes allergy-tested ingredients that are non-comedogenic, pH-balancing, and completely free of animal products.
Frequent washing will not cause dryness or irritation, and DermaWash will not aggravate rosacea, eczema, psoriasis, and many varieties of skin allergies.
DermaWash 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.
Designed for daily use, DermaWash can also serve as an ideal cleanser for pre-peel preparation of skin. -
Indications & Usage
DermaWash 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: deionized water, sodium lauryl sulfate, monoalkyl phosphate, triethanolamine, ethylene glycol distearate, sodium laureth sulfate, glycol distearate, cocamide-mea, laureth-10, myristic acid, diethanolamine, lauryl betaine, lauric acid, polysorbate 80, tocopherol acetate, DMDM hydantoin, light fragrance.
- Warnings
- Keep out of reach of children
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Front and Back Labels
KAVI DermaWash provides an ideal approach to cleansing normal or combination skin with pH sensitivity. DermaWash utilizes allergy-tested ingredients that are non-comedogenic, pH-balancing, and completely free of animal products.
Frequent washing will not cause dryness or irritation, and DermaWash will not aggravate rosacea, eczema, psoriasis, and many varieties of skin allergies.
DermaWash 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.
Designed for daily use, DermaWash can also serve as an ideal cleanser for pre-peel preparation of skin.
Directions:
1. Rinse hands and face with warm water.
2. Dispense 1 to 2 pumps of cleanser onto palm.
3. Rub palms together, spreading cleanser to fingertips.
4. Cleanse face gently but thoroughly.
5. Rinse hands and face with warm water.
6. Repeat as needed.Active Ingredient: colloidal sulfur (1%). Inactive Ingredients: deionized water, sodium lauryl sulfate, monoalkyl phosphate, triethanolamine, ethylene glycol distearate, sodium laureth sulfate, glycol distearate, cocamide-mea, laureth-10, myristic acid, diethanolamine, lauryl betaine, lauric acid, polysorbate 80, tocopherol acetate, DMDM hydantoin, 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.
KAVI Skin Solutions, Inc.
San Francisco, CA · www.kaviskin.com
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INGREDIENTS AND APPEARANCE
DERMAWASH
sulfur soap soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42771-0035 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 1 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:42771-0035-1 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)