Country: United States
Language: English
Source: NLM (National Library of Medicine)
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)
Pharmaceutical Specialties, Inc.
TOPICAL
OTC DRUG
Purposes Anti-dandruff, Anti-seborrheic dermatitis Uses Controls and reduces the symptoms of dandruff and seborrheic dermatitis Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.
OTC monograph final
VANICREAM Z-BAR- PYRITHIONE ZINC SOAP 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._ ---------- VANICREAM™ Z-BAR _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 Use on affected areas in place of your regular soap Work up a rich lather using warm water and massage gently into affected areas Rinse well _OTHER INFORMATION_ Store at room temperature _INACTIVE INGREDIENTS_ sodium cocoyl isethionate, stearic acid, coconut acid, water, sodium isethionate, sodium cocoyl glycinate, sodium chloride, petrolatum, sorbitol, cetearyl alcohol, propanediol, ceteareth-20, simethicone, glyceryl stearate, PEG-30 stearate, sorbic acid _QUESTIONS?_ 1-800-325-8232 WWW.VANICREAM.COM Dist. by PHARMACEUTICAL SPECIALTIES, INC., ROCHESTER, MN 55901 1-800-325-8232 www.vanicream.com Made in Canada Vanicream is a trademark, or registered trademark of Pharmaceutical Specialties, Inc. in the US or other countries. ©PSI 2015. All rights reserved. SH21B NDC 45334-391-01 DERMATOLOGIST TESTED VANICREAM™ Z-BAR _Pyrithione Zinc 2%_ Seborrheic Dermatitis & Anti-dandruff Medicated Cleansing Bar Free of dyes, fragrance, masking fragrance, lanolin, parabens & formaldehyde releasers Gluten-Free for Sensi Read the complete document