Organic Sulfur Suspension

Manufacturer
KAVI Skin Solutions, Inc.
Effective date
2020-10-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:32:05

Label at a glance#

ProductOrganic Sulfur Suspension
Active ingredientSULFUR
Label structure9 sections

Label contents#

Full prescribing information#

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

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

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: precipitated sulfur (6.6%).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

RECENT MAJOR CHANGES SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 LabelsProduct Labels

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42771-0025-12023-01-30C16284748780-1f386c649-bb0f-0266-e053-dadaa90a7c1aOrganic Sulfur Suspension

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42771-0025-1Organic Sulfur Suspension1 g in 1 BOTTLE, PLASTICSUSPENSION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42771-0025ORGANIC SULFUR SUSPENSION (SULFUR SUSPENSION) SUSPENSION [KAVI SKIN SOLUTIONS, INC.]3Legacy NDC, 1 package rows20201021_8e5d8107-bd59-0bdc-e053-2a95a90a6c58.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42771-002542771-0025-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b221ecac-cc08-bf88-e053-2995a90a0acf8e5d8107-bd59-0bdc-e053-2a95a90a6c582020-10-20WarningsExact identifier
spl id: b221ecac-cc08-bf88-e053-2995a90a0acf
spl set id: 8e5d8107-bd59-0bdc-e053-2a95a90a6c58

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.