AQUA KAVI- sulfur soap

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)
Available from:
KAVI Skin Solutions, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
colloidal sulfur 1% (equivalent to precipitated sulfur 5%)…...acne treatment 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 for the treatment and prevention of oily, acne-prone skin 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 irrit
Authorization status:
OTC monograph final
Authorization number:
42771-0002-1

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

Purpos e

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

sulfur soap

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:42771-0 0 0 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

KAVI Skin Solutions, Inc.

Ingredient Name

Basis of Strength

Stre ng th

SULFUR (UNII: 70 FD1KFU70 ) (SULFUR - UNII:70 FD1KFU70 )

SULFUR

1 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

HYDRO GENATED PALM O IL (UNII: 257THB9 6 3H)

9 0 g in 10 0 g

SO DIUM CO CO YL ISETHIO NATE (UNII: 518 XTE8 49 3)

1 g in 10 0 g

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

1 g in 10 0 g

GLYCERIN (UNII: PDC6 A3C0 OX)

1 g in 10 0 g

1,2 -BUTANEDIO L (UNII: RUN0 H0 1QEU)

0 .5 g in 10 0 g

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

0 .25 g in 10 0 g

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:42771-0 0 0 2-1

1 g in 1 BOX; Type 0 : No t a Co mbinatio n Pro duct

0 5/0 1/20 0 3

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt358 H

0 5/0 1/20 0 3

Labeler -

KAVI Skin Solutions, Inc. (042927253)

Revised: 7/2019

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