SULPHO-LAC MEDICATED- sulfur soap
Bradford Soap Works, 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 INGREDIENT

SULFUR 5%

PURPOSE

ACNE TREATMENT SOAP

Keep out of reach of children

INDICATIONS

CLEARS UP BLACKHEADS AND ACNE PIMPLES AND ALLOWS SKIN TO HEAL
HELPS PREVENT NEW BLACKHEADS AND ACNE PIMPLES FROM FORMING
FOR USE IN THE MANAGEMENT OF ACNE

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

DO NOT GET INTO EYES
IF EXCESSIVE SKIN IRRITATION DEVELOPS OR INCREASES, DISCONTINUE USE AND CONSULT A PHYSICIAN
USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS ONLY ONE MEDICATION SHOULD BE USED UNLESS OTHERWISE DIRECTED BY A PHYSICAN

DIRECTIONS

GENTLY WASH AFFECTED AREA WITH SULPHO-LAC MEDICATED SOAP. ALLOW LATHER TO REMAIN ON SKIN FOR THREE TO FIVE MINUTES

RINSE THOROUGHLY WITH WARM WATER AND GENTLY PAT DRY WITH CLEAN TOWEL
MAY BE USED FROM ONE TO THREE TIMES A DAY
BECAUSE EXCESSIVE DRYNESS OF THE SKIN MAY OCCUR, START WITH ONE APPLICATION A DAY, THEN GRADUALLY INCREASE TO TWO OR THREE TIMES DAILY, IF NEEDED, OR AS DIRECTED BY A PHYSICIAN

OTHER INFORMATION

STORE AT ROOM TEMPERATURE 150 - 300 C (590 - 860 F).

INACTIVE INGREDIENTS

SODIUM TALLOWATE, SODIUM COCOATE, PURIFIED WATER, PENTASODIUM PENTETATE, TETRASODIUM ETIDRONATE, SODIUM PALM KERNELATE

PACKAGE IMAGE

SULPHO-LAC MEDICATED
sulfur soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11118-1008
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	5.0 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
COCONUT OIL (UNII: Q9L0O73W7L)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11118-1008-8	85 g in 1 BOX; Type 0: Not a Combination Product	02/20/2007	01/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	02/20/2007	01/01/2016

Labeler - Bradford Soap Works, Inc. (001201045)

Registrant - Bradford Soap Works, Inc. (001201045)

Name	Address	ID/FEI	Business Operations
Establishment
Bradford Soap Works, Inc.		001201045	manufacture(11118-1008) , label(11118-1008)

Name	Address	ID/FEI	Business Operations
Establishment
The Original Bradford Soap Works, Inc		362189503	manufacture(11118-1008) , label(11118-1008)

Name	Address	ID/FEI	Business Operations
Establishment
Jean Charles Mexicali SA de C.V.		824250179	manufacture(11118-1008) , label(11118-1008)

Revised: 6/2016

Document Id: b40f0f5c-497e-4043-adeb-139e15977a77

Set id: 2f838efd-831d-4171-8387-83c8eab3c51a

Version: 2

Effective Time: 20160630

Bradford Soap Works, Inc.