DERMAWASH- sulfur soap soap 
KAVI Skin Solutions, Inc.

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.

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DermaWash

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

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

Active Ingredient: colloidal sulfur (1%)

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

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

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

Product Front and Back Panels

DERMAWASH 
sulfur soap soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42771-0035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR1 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:42771-0035-11 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)

Revised: 10/2020
Document Id: b221ecac-cc07-bf88-e053-2995a90a0acf
Set id: aed17cfa-83f0-5035-e053-2995a90ae937
Version: 3
Effective Time: 20201020
 
KAVI Skin Solutions, Inc.