Label: ORGANIC SULFUR SUSPENSION- sulfur suspension suspension
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Contains inactivated NDC Code(s)
NDC Code(s): 42771-0025-1 - Packager: KAVI Skin Solutions, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated October 20, 2020
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- Dosage & Administration
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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
- Active Ingredients
- Inactive Ingredients
- Warnings
- Keep out of reach of children
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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
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INGREDIENTS AND APPEARANCE
ORGANIC SULFUR SUSPENSION
sulfur suspension suspensionProduct 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. (179144683)