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| Product NDC Code | 59088-488 | ||||
|---|---|---|---|---|---|
| Drug Name | Camphotrol |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 1039731 | ||||
| Application Number | M017 | ||||
| Labeler Name | PureTek Corporation | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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) Leaf Powder, 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.Camphotrol 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.Camphotrol® 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 feedingIf 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