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Camphotrex - Medication Information

Product NDC Code 59088-283
Drug Name

Camphotrex

Type Brand
Active Ingredients
Camphor (synthetic) 4 g/100g
Menthol 10 g/100g
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 1039731
Application Number M017
Labeler Name PureTek Corporation
Packages
Package NDC Code Description
59088-283-07 85 g in 1 bottle, with applicator (59088-283-07)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients (% by weight) Camphor 4% Menthol 10%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains, etc.

Purpose

Information about the drug product’s indications for use.
Purpose Analgesic (pain relief)

Spl product data elements

Usually a list of ingredients in a drug product.
Camphotrex camphor, menthol METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) ALCOHOL INDIAN FRANKINCENSE CHONDROITIN SULFATE (BOVINE) EUCALYPTUS OIL GLUCOSAMINE SULFATE GLYCERIN ILEX PARAGUARIENSIS LEAF MAGNESIUM CHLORIDE PEPPERMINT OIL DIMETHYL SULFONE PROPYLENE GLYCOL TROLAMINE WATER CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) MENTHOL MENTHOL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Camphotrex® Label

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use on ■ wounds ■ damaged skin

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
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

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product ■ avoid getting into eyes or mucous membranes ■ do not bandage tightly

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a health professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Other information ■ keep container tightly closed ■ store at 20° to 25°C (68° to 77°F)

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API