Active Ingredients

Pyrithione Zinc, 0.1%

Purpose

Antidandruff

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 help or call a poison control center at once.

Directions

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

Inactive Ingredients

water, Mineral Oil, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Stearyl Alcohol, Ceteareth-20, Sodium Carbomer, Simmondsia Chinensis (Jojoba) Seed Oil, Hydrolyzed Collagen, Propylene Glycol, Tocopheryl Acetate, Methylparaben, Propylparaben, Diazolidinyl Urea, Sodium Lauryl Sulfate, Panthenol, Fragrance.

Package Labeling

12022-029-00

SULFUR 8 FRESH ANTI-DANDRUFF OIL MOISTURIZING
pyrithione zinc lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:12022-029
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
JOJOBA OIL (UNII: 724GKU717M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
PANTHENOL (UNII: WV9CM0O67Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:12022-029-00	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/06/2008

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M032	02/06/2008

Labeler - J. Strickland & Co. (007023112)

Registrant - J. Strickland & Co. (007023112)

Name	Address	ID/FEI	Business Operations
Establishment
J. Strickland & Co.		007023112	manufacture(12022-029)

Sulfur 8 Fresh Anti-Dandruff Oil Moisturizing Lotion