ORGANIC SULFUR SUSPENSION- sulfur suspension suspension

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Active Ingredient: precipitated sulfur (6.6%).
Available from:
KAVI Skin Solutions, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
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. 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.
Authorization status:
OTC monograph final
Authorization number:
42771-0025-1

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.

Purpos e

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

ORGANIC SULFUR SUSPENSION

sulfur suspension suspension

KAVI Skin Solutions, Inc.

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:42771-0 0 25

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SULFUR (UNII: 70 FD1KFU70 ) (SULFUR - UNII:70 FD1KFU70 )

SULFUR

6 .6 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

TRIETHANO LAMINE BENZO ATE (UNII: M3EN4GC19 W)

0 .0 35 g in 10 0 g

PHENYLETHYL ALCO HO L (UNII: ML9 LGA746 8 )

20 g in 10 0 g

LIME ( CALCIUM O XIDE) (UNII: C7X2M0 VVNH)

0 .0 13 g in 10 0 g

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

0 .2 g in 10 0 g

CARBO MER 13 4 2 (UNII: 8 0 9 Y72KV36 )

0 .15 g in 10 0 g

WATER (UNII: 0 59 QF0 KO0 R)

71.9 2 g in 10 0 g

CAMPHO R ( NATURAL) (UNII: N20 HL7Q9 41)

10 g in 10 0 g

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:42771-0 0 25-

1 g in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 3/0 1/20 0 7

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt358 H

0 3/0 1/20 0 7

Labeler -

KAVI Skin Solutions, Inc. (179144683)

Revised: 10/2020

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