DERMAKLEAR AKNE TREATMENT WITH SULFUR- sulfur soap

DERMAKLEAR AKNE TREATMENT WITH SULFUR by

Drug Labeling and Warnings

DERMAKLEAR AKNE TREATMENT WITH SULFUR by is a Otc medication manufactured, distributed, or labeled by Schwabe North America, Inc, Bradford Soap Works, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DermaKlear

ACTIVE INGREDIENTS:

Sulfur 5%

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

Dosage and Administration:

Directions: Apply soap to hands or wash cloth. 

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.

INDICATIONS & USAGE

Indications and Usage:

For the treatment of acne. 

Dries acne blemishes and allows skin to heal. 

Helps prevent new acne blemishes from forming.

WARNINGS

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.

Apply only to areas with acne.

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:

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

ASK DOCTOR

Ask the Doctor:

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. 

OVERDOSAGE

Overdosage:

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

PURPOSE

Purpose:

Uses for the treatment of acne. 

Dries acne blemishes and allows skin to heal. 

Helps prevent new acne blemishes from forming.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMAKLEAR AKNE TREATMENT WITH SULFUR 
sulfur soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59800-0107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	5 g  in 85 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (DERMA KLEAR)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59800-0107-0	1 in 1 BOX	07/01/2004
1		85 g in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	07/01/2004

Labeler - Schwabe North America, Inc (831153908)

Establishment
Name	Address	ID/FEI	Business Operations
Bradford Soap Works, Inc		001201045	manufacture(59800-0107)