FREE AND CLEAR- pyrithione zinc shampoo

Free and Clear by

Drug Labeling and Warnings

Free and Clear by is a Otc medication manufactured, distributed, or labeled by Pharmaceutical Specialties, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient

Pyrithione zinc 2%

PURPOSE

Purposes

Anti-dandruff,

Anti-seborrheic dermatitis

INDICATIONS & USAGE

Uses

Controls and reduces the symptoms of dandruff and seborrheic dermatitis

WARNINGS

Warnings

For external use only

ASK DOCTOR

Ask a doctor before use if you have a condition that covers a large area of the body.

WHEN USING

When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

STOP USE

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information

Store at room temperature

INACTIVE INGREDIENT

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

Questions?

1-800-325-8232

www.vanicream.com

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PHARMACEUTICAL SPECIALTIES, INC.

ROCHESTER, MN 55901 Made in U.S.A.

www.vanicream.com 800-325-8232

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

FREE AND CLEAR 
pyrithione zinc shampoo

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Pharmaceutical Specialties, Inc. (076499557)

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