DERMAWASH- sulfur soap soap

DermaWash by

Drug Labeling and Warnings

DermaWash by is a Otc medication manufactured, distributed, or labeled by KAVI Skin Solutions, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

DERMAWASH 
sulfur soap soap

Product 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)