FDA.reportPublic FDA data

Aqua KAVI

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#

ProductAqua KAVI
Active ingredientSULFUR
Label structure8 sections

Indications and uses

drug facts active ingredients/purpose colloidal sulfur 1% (equivalent to precipitated sulfur 5%)…...acne treatment uses for the treatment and prevention of acne or as a non-inflammatory cleanser on skin diagnosed with eczema, rosacea, psoriasis, or other condition requiring a pH-balancing topical warnings ▪ for external use only ▪ keep out of reach of children when using this product avoid other antiseborrheics un...

Dosage and administration

▪ use as a replacement to your existing cleanser(s) ▪ lather using warm water and cleanse affected areas ▪ rinse and pat dry ▪ cleanse once to three times per day ▪ monitor skin for dryness or irritation and reduce application as needed

Label contents#

Full prescribing information#

active ingredients, purpose

OTC - ACTIVE INGREDIENT SECTION

colloidal sulfur 1%
(equivalent to precipitated sulfur 5%)…...acne treatment

Indications & Usage

INDICATIONS & USAGE SECTION

uses
for the treatment and prevention of oily, acne-prone skin

directions

▪ use as a replacement to your existing cleanser(s)
▪ lather using warm water and cleanse affected areas
▪ rinse and pat dry
▪ cleanse once to three times per day
▪ monitor skin for dryness or irritation and reduce application as needed

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

▪ use as a replacement to your existing cleanser(s)
▪ lather using warm water and cleanse affected areas
▪ rinse and pat dry
▪ cleanse once to three times per day
▪ monitor skin for dryness or irritation and reduce application as needed

Warnings

WARNINGS SECTION

▪ for external use only
▪ keep out of reach of children

when using this product avoid other antiseborrheics unless otherwise directed by your physician. use in conjunction with other oral or topical anti-acne drugs may increase dryness or irritation of the skin.

inactive ingredients

INACTIVE INGREDIENT SECTION

palm and palm kernel oil, vegetable-based moisturizer, glycerin, ethanol, water

Purpose

OTC - PURPOSE SECTION

for the treatment and prevention of oily, acne-prone skin

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

▪ for external use only
▪ keep out of reach of children

Active Ingredients, Uses, Warnings, Directions, Inactive Ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

drug facts

active ingredients/purpose

colloidal sulfur 1%
(equivalent to precipitated sulfur 5%)…...acne treatment
uses

for the treatment and prevention of acne or as a non-inflammatory cleanser on skin diagnosed with eczema, rosacea, psoriasis, or other condition requiring a pH-balancing topical

warnings

▪ for external use only
▪ keep out of reach of children

when using this product avoid other antiseborrheics unless otherwise directed by your physician. use in conjunction with other oral or topical anti-acne drugs may increase dryness or irritation of the skin.

directions

▪ use as a replacement to your existing cleanser(s)
▪ lather using warm water and cleanse affected areas
▪ rinse and pat dry
▪ cleanse once to three times per day
▪ monitor skin for dryness or irritation and reduce application as needed

inactive ingredients

palm and palm kernel oil, vegetable-based moisturizer, glycerin, ethanol, water

Aqua KAVI packagingAqua KAVI packaging

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2179844sulfur 1 % Medicated Bar SoapPSN3
2179844sulfur 0.01 MG/MG Medicated Bar SoapSCD3
2179844sulfur 1 % Medicated Bar SoapSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42771-0002-12023-01-30C16284748780-1f386c649-cfc2-0266-e053-dadaa90a7c1aAqua KAVI

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42771-0002-1Aqua KAVI1 g in 1 BOXSOAP13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42771-0002AQUA KAVI (SULFUR) SOAP [KAVI SKIN SOLUTIONS, INC.]3Legacy NDC, 1 package rows20201021_8e5d03fd-6d02-5e6e-e053-2a95a90a21a1.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42771-000242771-0002-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SULFUR70FD1KFU70ACTIB
HYDROGENATED PALM OIL257THB963HIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
1,2-BUTANEDIOLRUN0H01QEUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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-cc09-bf88-e053-2995a90a0acf8e5d03fd-6d02-5e6e-e053-2a95a90a21a12020-10-20WarningsExact identifier
spl id: b221ecac-cc09-bf88-e053-2995a90a0acf
spl set id: 8e5d03fd-6d02-5e6e-e053-2a95a90a21a1

Reported adverse events (FAERS/openFDA)#

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