TOPICOOL PAIN RELIEF GEL WITH CATS CLAW - Drug Facts

Manufacturer
TENSproducts, Inc.
Effective date
2018-11-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:57:09

Label at a glance#

ProductTopiCool Pain Relief with Cats Claw
Active ingredientMENTHOL, UNSPECIFIED FORM, CAMPHOR (NATURAL)
Label structure9 sections

Indications and uses

For the temporary relief of arthritis backache sprains strains

Dosage and administration

Adults and children 2 years of age and older apply to affected area not more than 4 times daily rub in thoroughly until gel is absorbed

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Camphor 0.4%

Menthol 4.5%

Purpose:

OTC - PURPOSE SECTION

External Analgesic

External Analgesic

Uses:

INDICATIONS & USAGE SECTION

For the temporary relief of

  • arthritis
  • backache
  • sprains
  • strains

Warnings:

WARNINGS SECTION

Use only as directed.
For external use only.

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor or pharmacist if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

pregnant or breastfeeding

Stop use and consult a doctor if

OTC - STOP USE SECTION

symptoms persist for more than 7 days

GENERAL PRECAUTIONS SECTION


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

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older apply to affected area not more than 4 times daily
  • rub in thoroughly until gel is absorbed

Other information:

OTHER SAFETY INFORMATION

Store at room temperature with cap closed.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL - 113.4 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopiCool™
Pain relief gel with Cat's Claw

NET WT 4 OZ (113.4g)

PRINCIPAL DISPLAY PANEL - 113.4 g Tube Label
PRINCIPAL DISPLAY PANEL - 113.4 g Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1435269camphor 0.4 % / menthol 4.5 % Topical GelPSN2
1435274TopiCool 0.4 % / 4.5 % Topical GelPSN2
1435274camphor 0.004 MG/MG / menthol 0.045 MG/MG Topical Gel [TopiCool]SBD2
1435269camphor 0.004 MG/MG / menthol 0.045 MG/MG Topical GelSCD2
1435269camphor 0.4 % / menthol 4.5 % Topical GelSY2
1435274TopiCool (camphor 0.4 % / menthol 4.5 % ) Topical GelSY2
1435274TopiCool Pain Relief (camphor 0.004 MG/MG / menthol 0.045 MG/MG) Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57698-100-042023-01-30C16284748780-1f386c64a-3a2b-0266-e053-dadaa90a7c1aTOPICOOL PAIN RELIEF GEL WITH CATS CLAW - Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57698-100-04TopiCool Pain Reliefwith Cats Claw113.4 g in 1 TUBEGEL113.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57698-100TOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]2Legacy NDC, 1 package rows20181103_7204f07b-f4cc-4ec6-a57f-122ed25987ec.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q9411
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q9411
MENTHOLACTIVE MOIETYL7T10EIP3A1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4F1
INDIAN FRANKINCENSEINACTIVE INGREDIENT4PW41QCO2M1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163021
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
TRIMETHYLOLPROPANEINACTIVE INGREDIENT090GDF4HBD1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
UNCARIA TOMENTOSA ROOTINACTIVE INGREDIENT9IGG929A0H1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57698-10057698-100-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 233 matching rows.

DailyMed ingredient, IID ingredient, UNII table
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PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii candidate
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POLYSORBATE 20POLYSORBATE 207T1F30V5YHSPRAY, METERED / NASAL40 mgExact identifier — unii candidate
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POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION / INTRAVENOUS30 mgExact identifier — unii candidate
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PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
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GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
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ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
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TROLAMINETROLAMINE9O3K93S3TKGEL / TRANSDERMAL6 mgExact identifier — unii candidate
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PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
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TROLAMINETROLAMINE9O3K93S3TKAEROSOL, FOAM / VAGINAL2 %w/wExact identifier — unii candidate
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PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
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PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
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PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
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EDETATE SODIUMEDETATE SODIUMMP1J8420LUCAPSULE / ORAL1 mgExact identifier — unii candidate
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TROLAMINETROLAMINE9O3K93S3TKSOLUTION / TOPICALNAExact identifier — unii candidate
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GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, SOLUTION / SUBCUTANEOUSNAExact identifier — unii candidate
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TROLAMINETROLAMINE9O3K93S3TKGEL, METERED / TOPICAL20 mgExact identifier — unii candidate
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GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
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PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
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GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
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GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
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PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3ELIXIR / ORAL9306 mgExact identifier — unii candidate
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GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
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GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
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GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
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TROLAMINETROLAMINE9O3K93S3TKDROPS / NASALNAExact identifier — unii candidate
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PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / TOPICAL5.28 %w/vExact identifier — unii candidate
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PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
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openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6ee1a4cb-7b12-45a8-b78d-572771d5aa867204f07b-f4cc-4ec6-a57f-122ed25987ec2018-11-01WarningsExact identifier
spl id: 6ee1a4cb-7b12-45a8-b78d-572771d5aa86
spl set id: 7204f07b-f4cc-4ec6-a57f-122ed25987ec

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.