VANICREAM- pyrithione zinc shampoo

Vanicream by

Drug Labeling and Warnings

Vanicream 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 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.

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

SPL UNCLASSIFIED SECTION

Dist. by

PHARMACEUTICAL SPECIALTIES, INC.

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

www.vanicream.com 1-800-325-8232

PRINCIPAL DISPLAY PANEL

NDC: 45334-206-08

Formerly known as Free & Clear™

VANICREAM™

Pyrithione Zinc 2%

Dandruff Shampoo

for Sensitive Skin

DERMATOLOGIST TESTED

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

Sulfate-free Betaine-free Gluten-free

8 fl oz (237 mL)

INGREDIENTS AND APPEARANCE

VANICREAM 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45334-206
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: 45334-206-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/03/2022
2	NDC: 45334-206-07	7.4 mL in 1 TUBE; Type 0: Not a Combination Product	01/03/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	01/03/2022

Labeler - Pharmaceutical Specialties, Inc. (076499557)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaceutical Specialties, Inc.		076499557	manufacture(45334-206)