CAMPHOTREX- camphor, menthol gel

Camphotrex by

Drug Labeling and Warnings

Camphotrex by is a Otc medication manufactured, distributed, or labeled by PureTek Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAMPHOTREX 
camphor, menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59088-283
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	4 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59088-283-07	85 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	04/12/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/12/2016

Labeler - PureTek Corporation (785961046)

Establishment
Name	Address	ID/FEI	Business Operations
PureTek Corporation		785961046	manufacture(59088-283)