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

12022-027-00

SULFUR 8 FRESH ANTI-DANDRUFF MOISTURIZING
pyrithione zinc cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:12022-027
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 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERIN (UNII: PDC6A3C0OX)
BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
DIMETHICONE (UNII: 92RU3N3Y1O)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
OLETH-20 (UNII: YTH167I2AG)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SUGARCANE (UNII: 81H2R5AOH3)
BETAINE (UNII: 3SCV180C9W)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
APPLE (UNII: B423VGH5S9)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HEXAPEPTIDE-11 (UNII: NCJ63WU6BY)
ALLANTOIN (UNII: 344S277G0Z)
AMINO ACIDS, SILK (UNII: V0L00EX1IA)
PANTHENOL (UNII: WV9CM0O67Z)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
SORBITAN TRIOLEATE (UNII: QE6F49RPJ1)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM SULFATE (UNII: 0YPR65R21J)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:12022-027-00	113 g in 1 JAR; 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(12022-027)

Sulfur 8 Fresh Anti-Dandruff Oil Moisturizing Cream