DERMAKLEAR AKNE TREATMENT WITH SULFUR- sulfur soap 
Schwabe North America, 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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DermaKlear Akne Treatment with Sulfur

Active Ingredients

Sulfur 5%

Inactive Ingredient

Aloe vera leaf

alpha-bisabolol
Chamomile flower extract
fo-ti root extract
glycerin (vegetable)
Hawthorn berry extract 
Pentasodium pentetate
Rosemary leaf extract
Sage aerial part extract
Sodium chloride
Sodium cocoate (coconut)
Sodium palmate

Tetrasodium etidronate
Water

Dosgae & Administration

Directions: Apply soap to hands or wash cloth. 

Gently wash affected areas one to three times daily. 

Leave on skin for several minutes, then rinse and pat dry. 

If bothersome drying or peeling occurs, reduce application to once a day or every other day.

Indications & Usage

For the treatment of acne. 

Dries acne blemishes and allows skin to heal. 

Helps prevent new acne blemishes from forming.

Purpose

For the treatment of acne.
Dries acne blemishes and allows skin to heal.
Helps prevent new acne blemishes from forming.

Warning

For external use only.

When using 

When using this product do not get into eyes; dryness or irritation of the skin may increase if other topical acne medications are used at the same time or immediately following use of this product.
If this occurs only one medication should be used unless directed by a doctor.
Apply only to areas with acne.

Do not use

Do Not Use on broken skin or large areas of skin.
Stop use and ask a doctor if excessive skin irritation develops or increases.

Keep Out of Reach of Children:

Keep out of reach of children.  If swallowed, seek medical hlep or contact a Poison Control Center immediately

Overdose

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

DermaKlear _01070_D01.jpg

DERMAKLEAR AKNE TREATMENT WITH SULFUR 
sulfur soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59800-0107
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR5 g  in 85 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CHAMOMILE (UNII: FGL3685T2X)  
GLYCERIN (UNII: PDC6A3C0OX)  
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
ROSEMARY (UNII: IJ67X351P9)  
SAGE (UNII: 065C5D077J)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM COCOATE (UNII: R1TQH25F4I)  
WATER (UNII: 059QF0KO0R)  
POLYGONATUM MULTIFLORUM ROOT (UNII: EYW899536C)  
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)  
SODIUM PALMATE (UNII: S0A6004K3Z)  
PALMITIC ACID (UNII: 2V16EO95H1)  
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
CRATAEGUS MONOGYNA FRUIT (UNII: KJI2JZT1TS)  
Product Characteristics
Colorwhite (DERMA KLEAR) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59800-0107-01 in 1 BOX07/01/200412/31/2022
185 g in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H07/01/200412/31/2022
Labeler - Schwabe North America, Inc (831153908)
Establishment
NameAddressID/FEIBusiness Operations
Bradford Soap Works, Inc001201045manufacture(59800-0107)

Revised: 11/2020
 
Schwabe North America, Inc