TOPICOOL PAIN RELIEF WITH CATS CLAW- menthol gel 
TENSproducts, 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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TOPICOOL PAIN RELIEF GEL WITH CATS CLAW - Drug Facts


Active Ingredients:

Camphor 0.4%

Menthol 4.5%

Purpose:

External Analgesic

External Analgesic

Uses:

For the temporary relief of

Warnings:

Use only as directed.
For external use only.

Do not use

  • with other topical products
  • on open wounds or damaged skin

Ask a doctor or pharmacist if you are

pregnant or breastfeeding

Stop use and consult a doctor if

symptoms persist for more than 7 days


Avoid contact with eyes
Do not bandage tightly
Keep away from excessive heat or open flame

KEEP OUT OF REACH OF CHILDREN.

In case of ingestion, seek professional assistance and contact poison control immediately.

Directions:

Other information:

Store at room temperature with cap closed.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aqua (Deionized Water), Boswellia Serrata Extract, Ethylhexylglycerin, Glycerin, Ilex Paraguariensis (Yerba Mate) Extract, Isopropyl Alcohol, Phenoxyethanol, Polysorbate-20, Propylene Glycol, Tetrasodium EDTA, Triethanolamine, Uncaria Tomentosa (Cat's Claw) Extract, Zemea Propanediol

Questions or Comments?

(866) 449-1010 or www.tensproducts.com

PRINCIPAL DISPLAY PANEL - 85.049 g Tube Label

TopiCool™
Pain relief gel with Cat's Claw

NET WT 3 OZ (85.049g)

Principal Display Panel - 85.049 g Tube Label
TOPICOOL PAIN RELIEF  WITH CATS CLAW
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57698-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM4.5 g  in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)0.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
WATER (UNII: 059QF0KO0R)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
EDETATE SODIUM (UNII: MP1J8420LU)  
TROLAMINE (UNII: 9O3K93S3TK)  
CAT'S CLAW (UNII: 9060PRM18Q)  
TRIMETHYLOLPROPANE (UNII: 090GDF4HBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57698-100-0385.049 g in 1 TUBE; Type 0: Not a Combination Product08/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/01/2013
Labeler - TENSproducts, Inc. (121251883)

Revised: 11/2018
Document Id: cdde8ffd-8f3a-422a-b054-0f191f6290a0
Set id: dea61545-a523-417c-9df8-f494c279e4ae
Version: 2
Effective Time: 20181101
 
TENSproducts, Inc.