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.
Organic Sulfur Suspension
FDA Label NDC 42771-0025
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kavi Skin Solutions, Inc. for the product Organic Sulfur Suspension (NDC 42771-0025). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding dosage & administration, purpose, indications & usage, active ingredients, inactive ingredients, warnings, keep out of reach of children, back label - complete, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Back Label - Complete
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
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 (Aal4)
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