SULFUR- sulfur soap soap 
Meixin Beauty & Health Care Products Co., Ltd.

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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78565-106
Sulfur soap

Active Ingredient

Sulfur10.0% ,Salicylic Acid3.0%

Purpose

Acne Treatment

Warnings

For external use only

Do not use

On broken skin on large areas of the skin

When Using This Product

Apply only to areas with acne.

Do not allow contact with the eyes and mucous membranes.

If undue skin irritation develops or increases , discontinue use and consult a physician.

Skin irritation and dryness are more likely to occur if you use another topical medication at the same time.

If irritation occurs , only use one topical acne medication at a time.

If undue skin irritation develops or increases , discontinue use and consult a physician.

Keep Out of Reach of Children.

If swallowed , get medical help or contact a Poison Control Center right away.

Directions

Make lather with sponge.

Apply to affected areas.

Leave lather on skin for 3 to 5 minutes.

Rinse thoroughly with water and gently pat dry with a clean toweI.

May be used 1 to 3 times a day or as directed by a doctor

Other information

Inactive ingredients

Sodium palmitate, Sodium palm kernelate, Water , Glycerin , Tetrasodium EDTA ,Soyethyl morpholinium ethosulfate , Lavender essential oil

Indications

For use in the management of acne.

Dries up blackheads and whiteheads.

Penetrates pores to eliminate most acne pimples.

Helps keep skin clear of new acne blemishes

Package Label - Principal Display Panel

120g 78565-106-01

78565-106-01

SULFUR 
sulfur soap soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78565-106
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID3 g  in 100 g
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LAVENDER OIL (UNII: ZBP1YXW0H8)  
SOYETHYL MORPHOLINIUM ETHOSULFATE (UNII: J8C5W5HH18)  
WATER (UNII: 059QF0KO0R)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SODIUM PALMITATE (UNII: JQ43KP6296)  
SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78565-106-02240 g in 1 BOX; Type 0: Not a Combination Product12/25/2021
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H12/25/2021
Labeler - Meixin Beauty & Health Care Products Co., Ltd. (421458605)
Establishment
NameAddressID/FEIBusiness Operations
Meixin Beauty & Health Care Products Co., Ltd.421458605manufacture(78565-106)

Revised: 12/2021
 
Meixin Beauty & Health Care Products Co., Ltd.