AQUA KAVI- sulfur soap 
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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Aqua KAVI

active ingredients, purpose

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

Indications & Usage

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

▪ 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

▪ 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

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

Purpose

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

Keep out of reach of children

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

Active Ingredients, Uses, Warnings, Directions, Inactive Ingredients

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 packaging

AQUA KAVI 
sulfur soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42771-0002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED PALM OIL (UNII: 257THB963H) 90 g  in 100 g
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) 1 g  in 100 g
ALCOHOL (UNII: 3K9958V90M) 1 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 1 g  in 100 g
1,2-BUTANEDIOL (UNII: RUN0H01QEU) 0.5 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 0.25 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42771-0002-11 g in 1 BOX; Type 0: Not a Combination Product05/01/2003
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H05/01/2003
Labeler - KAVI Skin Solutions, Inc. (179144683)

Revised: 10/2020
Document Id: b221ecac-cc09-bf88-e053-2995a90a0acf
Set id: 8e5d03fd-6d02-5e6e-e053-2a95a90a21a1
Version: 3
Effective Time: 20201020
 
KAVI Skin Solutions, Inc.