ESIKA Men Effective Control

Dosage form: liquid
Ingredients: Pyrithione Zinc 0.0036mg in 1mL
Labeler: Ventura Corporation (San Juan, P.R)
NDC Code: 13537-341

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.

─ôsika
MEN
shampoo
Effective Control

Drug Facts

Active Ingredients

Pyrithione Zinc (0.36%)

Purpose

Antidandruff

Uses
  • Helps stop irritation and flaking associated with dandruff:

Warnings
  • for external use only.

  • avoid contact with eyes. If contacts occurs, rinse eyes thoroughly with water.

  • if condition worsens or does not improve after regular use of this product as directed, consult a doctor (or physician).

  • 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 2 times a week or as directed by a doctor (or physician).

Other information
  • Ask a doctor before use if you have seborrheic dermatitis that covers a large area of the body.

Inactive ingredients

Aqua (water), sodium laureth sulfate, cocamidopropyl betaine, cocamide dea, dimethiconol , hydrolyzed soy protein, lauryl glucoside, coco-glucoside , glyceryl oleate, sodium chloride, hydrolyzed wheat protein, acrylates/c10-30 alkyl acrylate crosspolymer, triethanolamine, fragrance, guar hydroxypropyltrimonium chloride, glycol distearate, tea-dodecylbenzenesulfonate, tetrasodium edta, ci 77891 (titanium dioxide ), cocamide mea, laureth-10 , magnesium nitrate, citric acid, zinc chloride, butylene glycol, ci 19140 (yellow 5), methylchloroisothiazolinone , magnesium chloride, ppg-26-buteth-26, methylisothiazolinone, peg-40 hydrogenated castor oil, ci 42090 (blue 1), ci 14700 (red 4), apigenin, oleanolic acid, biotinoyl tripeptide-1.

PRINCIPAL DISPLAY PANEL - 300 ml Bottle Label

MEN

shampoo
Effective Control

For all types of hair

> controls symptoms of dandruff
   with pyrithione zinc
> Strengthens debilitated hair

─ôsika
300 ml e (10.1 fl.oz)

ESIKA   MEN EFFECTIVE CONTROL
pyrithione zinc liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-341
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione Zinc (Pyrithione Zinc) Pyrithione Zinc0.0036 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
sodium laureth sulfate 
cocamidopropyl betaine 
coco diethanolamide 
lauryl glucoside 
coco glucoside 
glyceryl monooleate 
sodium chloride 
trolamine 
glycol distearate 
tea-dodecylbenzenesulfonate 
edetate sodium 
titanium dioxide 
coco monoethanolamide 
laureth-10 
magnesium nitrate 
citric acid monohydrate 
zinc chloride 
butylene glycol 
fd&c yellow no. 5 
methylchloroisothiazolinone 
magnesium chloride 
methylisothiazolinone 
polyoxyl 40 hydrogenated castor oil 
fd&c blue no. 1 
fd&c red no. 4 
oleanolic acid 
Packaging
#Item CodePackage Description
1NDC:13537-341-01300 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H05/17/2011
Labeler - Ventura Corporation (San Juan, P.R) (602751344)
Establishment
NameAddressID/FEIOperations
Bel Star S.A. (Colombia)880160197MANUFACTURE

Revised: 05/2011
 
Ventura Corporation (San Juan, P.R)

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)