MADINA ACNE- sulfur soap

Madina Acne by

Drug Labeling and Warnings

Madina Acne by is a Otc medication manufactured, distributed, or labeled by Bradford Soap Works, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive Ingredient:

Sulfur 3%

Purpose

Acne Treatment Soap

Uses:

For relief and control of acne, pimples and blackheads.

Warnings:

• For external use only
• Do not get into eyes. if contact occurs, rinse eyes thoroughly with water
• Using other acne medications in conjunction with this product may cause added irritation.

Keep out of reach of children.

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

Stop use and consult a physician

if irritation continues or worsens.

Directions:

When using this product for the first time, try it on a small area of skin to test for reaction. Wash areas where acne is present and allow soap to remain for a few minutes then rinse thoroughly with water.

Inactive ingredients:

Sodium Palmate, Sodium Cocoate (OR) Sodium Palm Kernelate, Water (Aqua), Glycerin, Fragrance (Parfum), Sodium Chloride, Titanium Dioxide (Cl 77801), Butyrospermum Parki (Shea) Butter, Tetrasodium Etidronate, Pentasodium Pentetate, Tocopheryl Acetate, Green 8 (Cl 59040), Yellow 6 (Cl 15985), Yellow 10 (Cl 47005).

Madina Acne Treatment Cleansing Bar - product label

311322		1	8    44586 00073   9
SKIN CARE LABS ACNE TREATMENT CLEANSING BAR Madina Skin Care Labs Deep Cleaning Acne Treatment Soap helps control Acne, pimples and blackheads. Contains Shea Butter and Vitamin E to moisturize and strengthen skin. Natural sulfur aroma will dissipate after use.	mADinA PALM OIL MADINA® SKIN CARE LABS ACNE TREATMENT CLEANSING BAR With 3% Sulfur for Deep Cleansing 3.5 oz. (100g NET. WT.)	SKIN CARE LABS ACNE TREATMENT CLEANSING BAR Madina Skin Care Labs Deep Cleaning Acne Treatment Soap helps control Acne, pimples and blackheads. Contains Shea Butter and Vitamin E to moisturize and strengthen skin. Natural sulfur aroma will dissipate after use.	Drug Facts
			Active Ingredient……………………..…Purpose 3% Sulfur…………………………………Acne Treatment Soap
			Uses: For relief and control of acne, pimples and blackheads.
			Warnings: § For external use only. § Do not get into eyes. If contact occurs, rinse eyes thoroughly with water § Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately § Using other acne medications in conjunction with this product may cause added irritation. § Stop use and consult a physician if irritation continues or worsens.	Directions: When using this product for the first time, try it on a small area of skin to test for reaction. Wash areas where acne is present and allow soap to remain for a few minutes then rinse thoroughly with water. Inactive ingredients: Sodium Palmate, Sodium Cocoate (OR) Sodium Palm Kernelate, Water (Aqua) Glycerin, Fragrance (Parfum), Sodium Chloride, Titanium Dioxide (CI77891), Butyrospermium Parkii (Shea) Butter, Tetrasodium Etidronate, Pentasodium Pentetate, Tocopheryl Acetate, Green 8 (CI 59040), Yellow 6 (CI15985), Yellow 10 (CI 47005).
	MADINA INDUSTRIAL CORP. Brooklyn NY 11217 USA ©2013 All Rights Reserved Questions or Comments info@madinaonline.com www.madinaonline.com This Name & Design is a registered Trademark with U.S. Pat and TM Officials

INGREDIENTS AND APPEARANCE

MADINA ACNE 
sulfur soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11118-0073
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	3.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM PALMATE (UNII: S0A6004K3Z)
SODIUM COCOATE (UNII: R1TQH25F4I)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SHEA BUTTER (UNII: K49155WL9Y)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
D&C GREEN NO. 8 (UNII: I2W85YOX9L)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11118-0073-1	100 g in 1 CARTON; Type 0: Not a Combination Product	05/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	05/01/2017

Labeler - Bradford Soap Works, Inc. (001201045)

Registrant - Bradford Soap Works, Inc. (001201045)

Establishment
Name	Address	ID/FEI	Business Operations
Bradford Soap Works, Inc.		001201045	manufacture(11118-0073) , label(11118-0073)