GRANDPAS THYLOX ACNE TREATMENT WITH SULFUR- sulfur soap

GRANDPAS THYLOX ACNE TREATMENT WITH SULFUR by

Drug Labeling and Warnings

GRANDPAS THYLOX ACNE TREATMENT WITH SULFUR 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  3.0%

Purpose

Acne Treatment Soap

Uses

Acts four ways to improve blemished skin:

• Softens the hard shell of acne blemishes (keratolytic action).
• Helps dissolve and remove blackheads.
• Washes away excess oils which may cause blackheads. 
• Freshens skin by its thorough cleansing action.

Warings

For external use only. Using other topical acne medications at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. Do not get into eyes.

Stop use and ask a doctor if

excessive skin irritation develpoes or increases.

Keep out of reach of children

Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Use twice daily. Work up a lather with hands or washcloth and apply to affected areas without scrubbing. Let dry about one minute, rinse thoroughly, and pat dry.

Inactive Ingredients

Sodium Palmate, Sodium Cocoate*, Water, Glycerin, Fragrance, Titanium Dioxide, Tetrasodium Etidronate, Pentasodium Pentetate, Cosmetic Orange oxide. * May also contain Sodium Palm Kernelate.

PRINCIPAL DISPLAY PANEL

			THYLOX® ALL NATURAL, 100% VEGETABLE BASE ACNE TREATMENT WITH 3% SULFUR
	Drug Facts Active Ingredient          Purpose Sulfur 3%. .. Acne Treatment Soap Uses § For the treatment of acne. Warnings For external use only. Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation to the skin. If this occurs, only on medication should be used unless directed by a doctor. When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and ask a doctor if excessive skin irritation develops or increases. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Directions Work up a lather and gently massage into affected areas. Leave on for one minute, rinse thoroughly, and pat dry. Use morning and night for best results. Inactive ingredients Sodium Palmate®, Sodium Cocoate/Sodium Palm Kernelate, Water (Aqua), Glycerin, Jasminum Officinale (Jasmine) Oil, Cananga Odorata Leaf Oil, Glyine Soja (Soybean) Oil, Sodium Chloride, Sodium Gluconate	AN AGE-OLD TREATMENT FOR TROUBLED SKIN Ideal for skin prone to acne and inflammation, this treatment soap harnesses the healing properties of natural sulfur to prevent and eliminate breakouts, blackheads and excess oil. Also phthalates, sulfates, parabene, edta, gluten, animal by-products, artificial fragrances or colorants	THE GRANDPA  SOAP COMPANY THE GRANDPA SOAP CO. THYLOX® ACNE TREATMENT				FROM OUR FAMILY TO YOURS SINCE 1878
			3% SULFUR	HARDWORKING, SIMPLE, PURE INGREDIENTS ARE THE HEART OF OUR NATURALSOAPMAKING TRADITION FROM OUR FAMILY TO YOURS NET WT 3.25 OZ (926)	FACE & BODY BAR SOAP

INGREDIENTS AND APPEARANCE

GRANDPAS THYLOX ACNE TREATMENT WITH SULFUR 
sulfur soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11118-1006
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
PALM OIL (UNII: 5QUO05548Z)
COCONUT OIL (UNII: Q9L0O73W7L)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11118-1006-6	92 g in 1 BOX; Type 0: Not a Combination Product	02/20/2007

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

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(11118-1006) , label(11118-1006)