ORGANIC SULFUR SUSPENSION- sulfur suspension suspension

Organic Sulfur Suspension by

Drug Labeling and Warnings

Organic Sulfur Suspension 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:
Apply to skin one to two times per day after cleansing with a KAVI anti-acne cleanser (e.g., Coral KAVI or DermaWash S2). Reduce frequency of application if skin becomes too dry.

Purpose

Designed exclusively for nodular and cystic acne, the KAVI Organic Sulfur Suspension helps to achieve two important results: (1) the accelerated treatment of acne infection within pores, and (2) the dissolution of free acne and other bacteria on the surface of the skin.
The Organic Sulfur Suspension has many of the same benefits as our anti-acne cleansers. In a liquid suspension and without the cleansing ingredients, our sulfur can now be left on the skin throughout the day. To offset sulfur's scent, we've added camphor to give the suspension a soothing essence.

Indications & Usage

The KAVI Organic Sulfur Suspension is best suited for the treatment of acne-prone skin.

Directions:
Apply to skin one to two times per day after cleansing with a KAVI anti-acne cleanser (e.g., Coral KAVI or DermaWash S2). Reduce frequency of application if skin becomes too dry.

Active Ingredients

Active Ingredient: precipitated sulfur (6.6%).

Inactive Ingredients

Inactive Ingredients: ethanol, camphor, DMDM hydantoin, carbomer, fragrance, triethanolamine, calcium oxide, deionized water.

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

Designed exclusively for nodular and cystic acne, the KAVI Organic Sulfur Suspension helps to achieve two important results: (1) the accelerated treatment of acne infection within pores, and (2) the dissolution of free acne and other bacteria on the surface of the skin.
The Organic Sulfur Suspension has many of the same benefits as our anti-acne cleansers. In a liquid suspension and without the cleansing ingredients, our sulfur can now be left on the skin throughout the day. To offset sulfur's scent, we've added camphor to give the suspension a soothing essence.

Directions:
Apply to skin one to two times per day after cleansing with a KAVI anti-acne cleanser (e.g., Coral KAVI or DermaWash S2). Reduce frequency of application if skin becomes too dry.

Active Ingredient: precipitated sulfur (6.6%). Inactive Ingredients: ethanol, camphor, DMDM hydantoin, carbomer, fragrance, triethanolamine, calcium oxide, deionized water.

CAUTION: In case of eye contact, flush with cold water. For external use only. Keep out of reach of children.

KAVI Skin Solutions, Inc.
San Francisco, CA www.kaviskin.com

INGREDIENTS AND APPEARANCE

ORGANIC SULFUR SUSPENSION 
sulfur suspension suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42771-0025
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	6.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)	0.035 g  in 100 g
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)	20 g  in 100 g
LIME (CALCIUM OXIDE) (UNII: C7X2M0VVNH)	0.013 g  in 100 g
DMDM HYDANTOIN (UNII: BYR0546TOW)	0.2 g  in 100 g
CARBOMER 1342 (UNII: 809Y72KV36)	0.15 g  in 100 g
WATER (UNII: 059QF0KO0R)	71.92 g  in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941)	10 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42771-0025-1	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. (042927253)