Coral KAVI by KAVI Skin Solutions, Inc. CORAL KAVI- sulfur soap

Coral KAVI by

Drug Labeling and Warnings

Coral KAVI by is a Otc medication manufactured, distributed, or labeled by KAVI Skin Solutions, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

active ingredients, purpose

colloidal sulfur 2%
(equivalent to precipitated sulfur 10%)…...acne treatment
salicylic acid 3%.........................................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 2%
(equivalent to precipitated sulfur 10%)…...acne treatment
salicylic acid 3%.........................................acne treatment

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

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

INGREDIENTS AND APPEARANCE

CORAL KAVI 
sulfur soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42771-0001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	2 g  in 100 g
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42771-0001-1	1 g in 1 BOX; Type 0: Not a Combination Product	05/01/2003

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	05/01/2003

Labeler - KAVI Skin Solutions, Inc. (042927253)