Label: ESIKA- pyrithione zinc liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 13537-353-01 - Packager: Ventura Corporation (San Juan, P.R)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated May 18, 2011
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
- Other information
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Inactive ingredients
Aqua (water),sodium laureth sulfate, cocamidopropyl betaine, dimethicone, cocamide mipa, cetyl alcohol, sodium chloride, glycol distearate, parfum (fragrance), polyquaternium-7, guar hydroxypropyltrimonium chloride, citric acid, magnesium nitrate, aloe barbadensis leaf juice, hydrolyzed soy protein, hydrolyzed wheat protein, soluble collagen, zinc chloride, zinc pca, methylchloroisothiazolinone, magnesium chloride, methylisothiazolinone.
- PRINCIPAL DISPLAY PANEL - 400 ml Bottle Label
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INGREDIENTS AND APPEARANCE
ESIKA VITAL WITH ACTIVE Z 2-IN-1 DANDRUFF CONTROL
pyrithione zinc liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13537-353 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5) Pyrithione Zinc 0.0034 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) sodium laureth sulfate (UNII: BPV390UAP0) cocamidopropyl betaine (UNII: 5OCF3O11KX) dimethicone (UNII: 92RU3N3Y1O) cetyl alcohol (UNII: 936JST6JCN) sodium chloride (UNII: 451W47IQ8X) glycol distearate (UNII: 13W7MDN21W) citric acid monohydrate (UNII: 2968PHW8QP) magnesium nitrate (UNII: 77CBG3UN78) aloe vera leaf (UNII: ZY81Z83H0X) zinc chloride (UNII: 86Q357L16B) zinc pidolate (UNII: C32PQ86DH4) methylchloroisothiazolinone (UNII: DEL7T5QRPN) magnesium chloride (UNII: 02F3473H9O) methylisothiazolinone (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13537-353-01 400 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part358H 05/17/2011 Labeler - Ventura Corporation (San Juan, P.R) (602751344) Establishment Name Address ID/FEI Business Operations Bel Star S.A. (Colombia) 880160197 MANUFACTURE