CAMPHOTREX- camphor, menthol gel 
PureTek Corporation

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.

----------

Camphotrex™

Extra Strength Pain Relieving Gel Roll-on Applicator

Professional Therapy for Muscle & Joint Pain Relief

Active Ingredients (% by weight)

Camphor 4%

Menthol 10%

Purpose

Analgesic (pain relief)

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains, etc.

Warnings

For external use only

Do not use on

■ wounds ■ damaged skin

When using this product

■ avoid getting into eyes or mucous membranes ■ do not bandage tightly

Stop use and ask a doctor if

■ excessive irritation of the skin develops ■ condition worsens
■ symptoms last more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

■ adults and children 12 years of age or older: using the roll-on applicator massage a liberal amount of gel directly on the affected area, not more than 3 to 4 times daily 
■ children under the age of 12: do not use, consult a doctor ■ use only as directed

Other information

■ keep container tightly closed ■ store at 20° to 25°C (68° to 77°F)

Inactive ingredients

Acrylates Copolymer, Alcohol Denat., Boswellia Serrata Extract, Chondroitin Sulfate, Eucalyptus Globulus Leaf Oil, Glucosamine Sulfate, Glycerin, Ilex Paraguariensis (Yerba Mate), Magnesium Chloride, Mentha Piperita (Peppermint) Oil, MSM (Methylsulfonylmethane), Propylene Glycol, Triethanolamine, Water.

Camphotrex®

Label

CAMPHOTREX 
camphor, menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-283
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
ALCOHOL (UNII: 3K9958V90M)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
GLYCERIN (UNII: PDC6A3C0OX)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59088-283-0785 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product04/12/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/12/2016
Labeler - PureTek Corporation (785961046)

Revised: 1/2023
Document Id: f204d934-e914-49e2-e053-2995a90a2383
Set id: 3b6c6eef-e92d-497d-afe8-82356637c2b8
Version: 4
Effective Time: 20230111
 
PureTek Corporation