FREE AND CLEAR- pyrithione zinc shampoo
Pharmaceutical Specialties, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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FREE & CLEAR™ Medicated Anti-dandruff Shampoo

Drug Facts

Active Ingredient

Pyrithione zinc 2%

Purposes

Anti-dandruff,

Anti-seborrheic dermatitis

Uses

Controls and reduces the symptoms of dandruff and seborrheic dermatitis

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 the 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 contact a Poison Control Center right away.

Directions

For best results use at least twice a week or as directed by a doctor
Shake before use
Wet hair and massage gently into scalp
Leave lather on scalp for several minutes
Rinse well, repeat if needed

Other information

Store at room temperature

Inactive ingredients purified water, lauryl glucoside, coco-glucoside, acrylates copolymer, panthenol, pentylene glycol, glycerin, sucrose cocoate, disodium cocoyl glutamate, sodium cocoyl glycinate, behenyl alcohol, sucrose stearate, cetyl palmitate, sodium cocoyl glutamate, 1,2-hexanediol, sodium hydroxide, caprylyl glycol, sodium chloride

Questions?

1-800-325-8232

www.vanicream.com

PHARMACEUTICAL SPECIALTIES, INC.

ROCHESTER, MN 55901 • Made in U.S.A.

www.vanicream.com • 800-325-8232

NDC 45334-205-08

DERMATOLOGIST RECOMMENDED

FREE & CLEAR™

Pyrithione Zinc 2%

Medicated Anti-dandruff Shampoo

for Sensitive Skin

Free of dyes, fragrance, masking fragrance, lanolin, protein, parabens, formaldehyde

Sulfate-free • Betaine-free • Gluten-free

8 fl oz (237 mL)

FC AntiDandruff Rev

FREE AND CLEAR
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45334-205
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	2 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)
SUCROSE COCOATE (UNII: 3H18P0UK73)
SUCROSE STEARATE (UNII: 274KW0O50M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
COCO GLUCOSIDE (UNII: ICS790225B)
SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)
WATER (UNII: 059QF0KO0R)
DOCOSANOL (UNII: 9G1OE216XY)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
GLYCERIN (UNII: PDC6A3C0OX)
DEXPANTHENOL (UNII: 1O6C93RI7Z)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:45334-205-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/02/2017	12/31/2023
2	NDC:45334-205-07	7.4 mL in 1 TUBE; Type 0: Not a Combination Product	03/10/2017	10/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	02/02/2017	12/31/2023

Labeler - Pharmaceutical Specialties, Inc. (076499557)

Name	Address	ID/FEI	Business Operations
Establishment
Pharmaceutical Specialties, Inc.		076499557	manufacture(45334-205)

Revised: 2/2022

Document Id: d8c98594-37e6-1ce3-e053-2995a90abb7a

Set id: 45e85a58-b21f-2ac7-e054-00144ff88e88

Version: 2

Effective Time: 20220224

Pharmaceutical Specialties, Inc.