BOTANIMEDIX TINEARX ANTIFUNGAL DRYING EMULSION- clotrimazole cream 
Cosco International, 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.

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Botanimedix TineaRX Antifungal Drying Emulsion

DRUG FACTS

Active Ingredient                          Purpose
Clotrimazole 1%........................Anti-fungal

Uses:

Cures most athlete's foot, jock itch, and ring worm

For relief of:

Directions:

Apply twice daily for best results.

Warnings:

For external use only.

When using this product

Stop use and ask a doctor if:

Inactive Ingredients:

Aluminum Starch Octenylsuccinate, Cannabidiol, Clove Leaf Oil, Dipropylene Glycol, Eucalyptus Oil, Glyceryl Monostearate, Hypromellose, Isopropyl Myristate, Isopropyl Palmitate, Peppermint Oil, Phenoxyethanol, Ethylhexylglycerin, Polyoxyl 20 Cetostearyl Ether, Tea Tree Oil, Water

Questions?

Call:  1-800-964-5406

www.botanimedix.com

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BOTANIMEDIX TINEARX ANTIFUNGAL DRYING EMULSION 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-5801
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE0.01 kg  in 1 kg
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
WATER (UNII: 059QF0KO0R)  
TEA TREE OIL (UNII: VIF565UC2G)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CANNABIDIOL (UNII: 19GBJ60SN5)  
CLOVE LEAF OIL (UNII: VCA5491KVF)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52261-5801-01 in 1 CARTON01/30/2020
1NDC:52261-5801-10.044 kg in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/2020
Labeler - Cosco International, Inc. (016433141)
Registrant - Cosco International, Inc. (016433141)
Establishment
NameAddressID/FEIBusiness Operations
Cosco International, Inc.016433141manufacture(52261-5801) , label(52261-5801) , pack(52261-5801)

Revised: 1/2020
Document Id: cbb76405-cf2a-49cc-aa80-1495a316afd7
Set id: dc80f53b-850e-40e6-9844-2b3b138ae172
Version: 3
Effective Time: 20200130
 
Cosco International, Inc.