OKAY FACIAL SOAP BAR- SULFUR ACNE TREATMENT 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]

SULFUR ACNE TREATMENT- sulfur soap 
Xtreme Tools International, Inc

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OKAY FACIAL SOAP BAR- SULFUR ACNE TREATMENT SOAP

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

NDC: 74553-13-01

MIAMI SKIN-Facial Soap

SULFUR ACNE TREATMENT 
sulfur soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 74553-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 74553-013-01155 g in 1 BOX; Type 0: Not a Combination Product09/12/202303/13/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00609/12/202303/13/2025
Labeler - Xtreme Tools International, Inc (125398904)

Revised: 3/2025
Document Id: 4a9270cc-1e00-45eb-886b-23055e330eb8
Set id: 2ddcb2ec-c93c-47cc-88f5-3e83a0cf3659
Version: 5
Effective Time: 20250321