DERMAKLEAR AKNE TREATMENT WITH SULFUR - sulfur soap 
Enzymatic Therapy, 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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ACTIVE INGREDIENTS HPUS:

Sulfur

INACTIVE INGREDIENT:

Aloe vera leaf

Chamomile (Matricaria recutita) flower extract 5:1

fo-ti (Polygonum multiflorum) root extract 5:1

Vegetable glycerin

Glycyrrhetinic acid

Hawthorn (Crataegus monogyna) berry extract 5:1

Pentasodium pentetate

Rosemary (Rosmarinus officinalis) leaf extract 5:1

Sage (Salvia officinalis) aerial part extract 5:1

Sodium chloride

Sodium cocoate

Sodium palm kernalate

Sodium palmate

Tetrasodium etidronate

Titanium dioxide

Water

PURPOSE:

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

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


INDICATIONS AND USAGE:

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

Directions:
Apply soap to hands or washcloth.  Gently wash affected areas one to three times daily.  Leave on skin for several minutes.  Rinse and pat dry.  If bothersome drying or peeling occurs, reduce application to once a day or every other day.

WARNINGS:

For external use only.

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.

Stop use and ask a doctor if excessive skin irritation develops or increases.

DOSAGE:

Apply soap to hands or washcloth.  Gently wash affected areas one to three times daily.  Leave on skin for several minutes.  Rinse and pat dry.  If bothersome drying or peeling occurs, reduce application to once a day or every other day.



DermaKlear 01070_B04

DermaKlear 01070_B04





DERMAKLEAR AKNE TREATMENT WITH SULFUR 
sulfur soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59800-0107
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (SULFUR) SULFUR5 g  in 85 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
CHAMOMILE 
GLYCERIN 
PROPYLENE GLYCOL 
HAWTHORN LEAF WITH FLOWER 
PENTASODIUM PENTETATE 
ROSEMARY 
SAGE 
SODIUM CHLORIDE 
SODIUM COCOATE 
SODIUM PALM KERNELATE 
TITANIUM DIOXIDE 
WATER 
POLYGONATUM MULTIFLORUM ROOT 
GLYCYRRHIZIN 
ETIDRONATE TETRASODIUM 
SODIUM PALMATE 
Product Characteristics
Colorwhite (DERMA KLEAR) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:59800-0107-01 in 1 BOX
185 g in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H07/01/2004
Labeler - Enzymatic Therapy, Inc. (056544166)
Establishment
NameAddressID/FEIBusiness Operations
Hunter Amenities International244071015manufacture

Revised: 06/2011
 
Enzymatic Therapy, Inc.