ZAPOTOL CLOTRIMAZOLE- clotrimazol cream 
Zapotol Corp.

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.

----------

Active ingredient                                                         Purpose

Clotrimazole 1%--------------------------------------------- Antifungal

Uses

Warnings

Do not use on children under 2 years of age except under the advice and supervision of a doctor

For external use only

When using this product avoid contact with the eyes

Stop use and ask a doctor if

Keep out of reach of childern

If swallowed, get medical help or contact a Poison Control Center right away.

Direction

Other information

Lot No. & Exp. Date;see box or see crimp of the tube

Store between 20°C to 25°C (68°F to 77°F)

Inactive ingredients

benzyl alcohol, isopropyl myristate, liquid paraffin, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearic acid, stearyl alcohol

DISTRIBUTED BY:

PRODUCTOS ZAPOTOL CORP.

Van Nuys, CA 91402

888-927-6865

Made in Korea

image description

ZAPOTOL CLOTRIMAZOLE 
clotrimazol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59428-359
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PARAFFIN (UNII: I9O0E3H2ZE)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59428-359-281 in 1 CARTON10/13/2016
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/07/2012
Labeler - Zapotol Corp. (186063850)

Revised: 10/2016
Document Id: b19b783a-4b82-4f68-a03c-b01c029efad8
Set id: 7d5f66e9-12b2-4251-861d-3ed354f76c31
Version: 2
Effective Time: 20161013
 
Zapotol Corp.