Active Ingredients

Salicylic Acid, 2%

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

12022-028-00

SULFUR 8 FRESH ANTI-DANDRUFF
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:12022-028
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:12022-028-00	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(12022-028)

Sulfur 8 Fresh Anti-Dandruff Spray