BOTANIMEDIX ONYCHORX ANTIFUNGAL NAIL GEL- undecylenic acid gel 
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 OnychoRX Antifungal Nail Gel

DRUG FACTS

Active Ingredient Purpose
Undecylenic Acid 25%........................Anti-fungal

Uses:

For the cure of most Tinea Pedis (athlete's foot) and Tinea Corporis (ringworm)

For relief of:

Itching, Burning, Redness, Irratation, Scaling, Soreness
Discomfort which may accompany these conditions

Directions:

Apply twice daily for best results.

Warnings:

For external use only.

When using this product

  • Do not get into eyes.

Stop use and ask a doctor if:

  • Condition worsens.
  • Symptoms last more than 7 days or clear and occur again within a few days.

Keep out of reach of children.

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

Inactive Ingredients:

Alpha Tocopheryl Acetate (Vitamin E), Cannabidiol, Cetostearyl Alchohol, Clove Leaf Oil, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Oil, Glyceryl Monostearate, Hypromellose, Isopropyl Palmitate, Peppermint Oil, Phenoxyethanol, Polysorbate 60, Propolis Wax, Tea Tree Oil, Urea, Water

Questions?

Call: 1-800-964-5406

www.botanimedix.com

Distributed by:

BotaniMedix

Atlanta, GA 30067

labellabellabel

carton

BOTANIMEDIX ONYCHORX ANTIFUNGAL NAIL GEL 
undecylenic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52261-5800
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID0.2508 kg  in 1 kg
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
UREA (UNII: 8W8T17847W)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
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)  
DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52261-5800-01 in 1 CARTON01/01/2020
1NDC:52261-5800-10.002 kg in 1 BOTTLE, WITH APPLICATOR; 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(52261-5800) , label(52261-5800) , pack(52261-5800)

Revised: 1/2020
Document Id: 0c4206d2-bb4d-4adc-9546-67081c2f47f9
Set id: 16e8a074-905e-41b5-bb46-c7bb3e914f7a
Version: 3
Effective Time: 20200129
 
Cosco International, Inc.