SPAI-SONS ACID ANTI-DANDRUFF- sulfur shampoo

SPAI-SONS by

Drug Labeling and Warnings

SPAI-SONS by is a Otc medication manufactured, distributed, or labeled by SPAI-SONS PHARAMCUETICAL INTERNATIONAL COSMETICS, SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

This formula includes Biosulfur fluid, that is highest effectiveness for the scalp.

PURPOSE

This fromula includes the active ingredient containing the highest effectiveness for the scalp called greasy dandruff

KEEP OUT OF REACH OF CHILDREN

This product must be keep out reach of children

INDICATIONS & USAGE

This product is for topical application. Wash the hair with the shampoo in the shower

WARNINGS

If this product is contact with eyes rinse immediately with water and consult your doctor.

DOSAGE & ADMINISTRATION

To wash daily during 8 or 10 weeks, soon interdaily use until the remission of the problem. The product is for topical application.

INACTIVE INGREDIENT

Its components make it tolerable for daily use or washing the scalp affected

PRINCIPAL DISPLAY PANEL

IMAGE OF THE LABEL

INGREDIENTS AND APPEARANCE

SPAI-SONS  ACID ANTI-DANDRUFF
sulfur shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66854-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	0.4 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
LAURETH-10 (UNII: BD7AST04GA)
DIPYRITHIONE (UNII: 9L87N86R9A)
PANTHENOL (UNII: WV9CM0O67Z)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TROLAMINE (UNII: 9O3K93S3TK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66854-021-01	210 mL in 1 BOTTLE
2	NDC: 66854-021-02	250 mL in 1 BOTTLE
3	NDC: 66854-021-03	250 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	06/30/2012

Labeler - SPAI-SONS PHARAMCUETICAL INTERNATIONAL COSMETICS (880172184)

Registrant - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS (880172184)

Establishment
Name	Address	ID/FEI	Business Operations
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS		880172184	analysis, label, manufacture, pack