SULFUR 8 AQUA BLUE- pyrithione zinc shampoo, suspension

Sulfur 8 Aqua Blue by

Drug Labeling and Warnings

Sulfur 8 Aqua Blue 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, 1%

Purpose

Antidandruff

Use:

relieves scalp itching, irritation, redness, scaling and flaking associated with 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

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

Stop use and consult a doctor if

• conditions 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 twice a week 
• wet hair, apply shampoo, lather, rinse & repeat

Inactive Ingredients

SD Alcohol 40, Water, Propylene Glycol, Benzyl Alcohol, Menthol.

Package Labeling

INGREDIENTS AND APPEARANCE

SULFUR 8 AQUA BLUE 
pyrithione zinc shampoo, suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 12022-024
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
GLYCOL STEARATE (UNII: 0324G66D0E)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
BENZYL ALCOHOL (UNII: LKG8494WBH)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
TRIETHYLENE GLYCOL (UNII: 3P5SU53360)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 12022-024-00	222 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/15/2002

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	07/15/2002

Labeler - J. Strickland & Co. (007023112)

Registrant - J. Strickland & Co. (007023112)

Establishment
Name	Address	ID/FEI	Business Operations
J. Strickland & Co.		007023112	manufacture(12022-024) , pack(12022-024) , label(12022-024)