SULFUR 8 FIVE STAR ANTI-DANDRUFF HAIR GROOM- pyrithione zinc cream

Sulfur 8 Five Star Anti-Dandruff Hair Groom by

Drug Labeling and Warnings

Sulfur 8 Five Star Anti-Dandruff Hair Groom by is a Otc medication manufactured, distributed, or labeled by J. Strickland & Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Pyrithione Zinc, 0.1%

Purpose

Anti-dandruff

Use:

Controls scalp itching and flaking due to dandruff

Warnings:

For external use only

When using this product

• do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and consult a doctor if 

• condition worsens or does not improve after regular use.

Keep out of reach of children

If swallowed, get medical helpor call a poison contril center at once.

Directions

• Apply to the affected area 1-4 times daily, or as dircted by a doctor.

Inactive Ingredients

Water, Petrolatum, Mineral Oil, Glycerin, Ricinis Communis (Castor) Seed Oil, Stearyl Alcohol, Behentrimonium Methosulfate, Beeswax (Cera Alba), Dimethicone, Lanolin, Oleth-20, Polyquaterinium-11, Allantoin, Panthenol, Propylene Glycol, Butylene Glycol, Cetyl Alcohol, Sorbitan Trioleate, Diazolidinyl Urea, Methylparaben, Sodium Sulfate, Propylparaben, Fragrance (Parfum). 

Package Labeling

INGREDIENTS AND APPEARANCE

SULFUR 8 FIVE STAR ANTI-DANDRUFF HAIR GROOM 
pyrithione zinc cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12022-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERIN (UNII: PDC6A3C0OX)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
DIMETHICONE (UNII: 92RU3N3Y1O)
LANOLIN (UNII: 7EV65EAW6H)
OLETH-20 (UNII: YTH167I2AG)
ALLANTOIN (UNII: 344S277G0Z)
PANTHENOL (UNII: WV9CM0O67Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL ALCOHOL (UNII: 936JST6JCN)
SORBITAN TRIOLEATE (UNII: QE6F49RPJ1)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM SULFATE (UNII: 0YPR65R21J)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12022-030-00	99 g in 1 TUBE; Type 0: Not a Combination Product	04/29/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	04/29/2010

Labeler - J. Strickland & Co. (007023112)

Registrant - J. Strickland & Co. (007023112)

Establishment
Name	Address	ID/FEI	Business Operations
J. Strickland & Co.		007023112	manufacture(12022-030) , pack(12022-030) , label(12022-030)