Drug Facts

Active Ingredient

Pyrithione Zinc, 1%

Purpose

Antidandruff

Use

Controls scalp itching an flaking due to dandruff

Warnings

For external use only

Ask a doctor before use if you have

seborrheic dermatitis that covers a large area of the body.

When using this product

avoid contact with 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 right away.

Directions

shake well. for best results, use at least twice a week
wet hair, apply shampoo. lather, rinse & repeat

Inactive Ingredients

Water, Ammonium Lauryl Sulfate, Propylene Glycol, Ammonium Laureth Sulfate, Cocamidopropyl Betaine, PEG-3 Glyceryl Cocoate, Hydroxypropyl Methylcellulose, Sodium Cocoamphopropionate, Glycol Distearate, Glycol Stearate, Glycol, Magnesium Aluminum Silicate, Benzyl Alcohol, Methylchloroisothiazolinone, Methylisothiazolinone, Triethylene Glycol, Magnesium Nitrate, Copper Sulfate, Citric Acid, Fragrance, Blue 1

Package Labeling:

Label5

SULFUR 8 SCALP THERAPY MEDICATED DANDRUFF CONTROL
pyrithione zinc shampoo, suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:12022-036
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
GLYCOL STEARATE (UNII: 0324G66D0E)
ETHYLENE GLYCOL (UNII: FC72KVT52F)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
BENZYL ALCOHOL (UNII: LKG8494WBH)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
TRIETHYLENE GLYCOL (UNII: 3P5SU53360)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
CUPRIC SULFATE (UNII: LRX7AJ16DT)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:12022-036-00	280 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M032	01/01/2020

Labeler - J. Strickland and Co. (007023112)

Sulfur 8 Scalp Therapy Medicated Dandruff Control Shampoo