SULFUR ACNE TREATMENT- sulfur soap

SULFUR ACNE TREATMENT by

Drug Labeling and Warnings

SULFUR ACNE TREATMENT by is a Otc medication manufactured, distributed, or labeled by Xtreme Tools International, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Sulfur (10%)

Purpose

Acne Treatment

Use

For the treatment of acne.

Warning

For External use only

When using this product

■ apply only to areas with acne. ■ skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical medication at a time. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Do not use on

■ broken skin ■ Large areas of the skin.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet face. Work soap into a lather with hands and gently massage onto skin. Rinse.

Inactive Ingredients

Sodium Palmate, Sodium Palm Kernelate, Sodium Cocoate, Water (Aqua), Glycerin, Cocos nucifera (Coconut) Oil, Rosa Moschata Seed (Rosehip) Oil, Psidium Guajava Leaf Extract, Carica Papaya (Papaya) Fruit Extract, Allantoin, Tocopheryl Acetate, Tetrasodium Etidronate, Sodium Chloride, Fragrance.

QUESTIONS

Questions or comments?
Call 1-305-622-7474 Mon-Fri 9 am-5 pm

Pacakge Label

NDC: 74553-13-01

INGREDIENTS AND APPEARANCE

SULFUR ACNE TREATMENT 
sulfur soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74553-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM PALMATE (UNII: S0A6004K3Z)
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)
SODIUM COCOATE (UNII: R1TQH25F4I)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
COCONUT OIL (UNII: Q9L0O73W7L)
ROSA MOSCHATA SEED OIL (UNII: T031ZE559T)
PSIDIUM GUAJAVA LEAF (UNII: PM0F263X0Y)
PAPAYA (UNII: KU94FIY6JB)
ALLANTOIN (UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74553-013-01	155 g in 1 BOX; Type 0: Not a Combination Product	09/12/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M006	09/12/2023

Labeler - Xtreme Tools International, Inc (125398904)