ORGANIC SULFUR SUSPENSION- sulfur suspension suspension 
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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Organic Sulfur Suspension

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

Product Labels

ORGANIC SULFUR SUSPENSION 
sulfur suspension suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42771-0025
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42771-0025-11 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-cc08-bf88-e053-2995a90a0acf
Set id: 8e5d8107-bd59-0bdc-e053-2a95a90a6c58
Version: 3
Effective Time: 20201020
 
KAVI Skin Solutions, Inc.