Drug Facts

Active Ingredient

Salicylic Acid, 2%

Purpose

Antidandruff, Seborrheic dermatitis, Psoriasis.

Uses

control the symptoms of

dandruff
seborrheic dermatitis
psoriasis

Warnings

For external use only

Ask a doctor before use

if you have

a condition 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 ask a doctor

if condition worsens or does not improve after regular use of this product as directed.

Keep out of reach of children.

If swallowed, get medical help or call a Poison Control Center right away.

Directions

For best results, use at least twice a week or as directed by a doctor.
Apply a liberal amount of shampoo and massage into lather.
Allow lather to remain on scalp for a few minutes.
Rinse and repeat.

Inactive Ingrdients

Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Sodium Chloride, Polyquaternium-22, Menthol, Aloe Barbadensis Leaf Extract, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Disodium EDTA, Sodium Benzoate, Citric Acid, Potassium Sorbate, Sodium Sulfite, Sodium Hydroxide, Benzyl Benzoate, Fragrance.

Package Labeling:

Label

SULFUR 8 MEDICATED DANDRUFF WITH SALICYLIC ACID
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:12022-039
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)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
MENTHOL (UNII: L7T10EIP3A)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM SULFITE (UNII: VTK01UQK3G)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BENZYL BENZOATE (UNII: N863NB338G)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:12022-039-00	222 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M032	10/01/2023

Labeler - J. Strickland and Co. (007023112)

Sulfur 8 Medicated Dandruff Shampoo with Salicylic Acid