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| Product NDC Code | 60954-012 | ||||
|---|---|---|---|---|---|
| Drug Name | Eagle brand medicated roll on refresh |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OIL | ||||
| RxCUI drug identifier | 2672336 | ||||
| Application Number | M017 | ||||
| Labeler Name | PT. EAGLE INDO PHARMA | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Camphor 2.2% Menthol 14%
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 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients beta carotene, clove oil, D&C Red No.17, fragrance, light mineral oil, peppermint oil
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 temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains, and itching associated with • insect bites.
Purpose
Information about the drug product’s indications for use.Purpose External Analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Eagle Brand Medicated Roll On Refresh camphor, menthol D&C RED NO. 17 BETA CAROTENE PEPPERMINT OIL CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) MENTHOL MENTHOL CLOVE OIL LIGHT MINERAL OIL
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.Package Label 8ml NDC: 60954-012-08 8ml Unit Box
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 Centre right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Store below 86 o F (30 o C).
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? If there are any questions or to report serious side effects, call 1-800-777-6717 or 1-800-645-0769.
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 Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
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 the eyes or on mucous membranes. • Do not apply to wounds or damaged skin. • Do not bandage tightly. • Do not use otherwise than as directed.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding Ask a health professional before use.
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 When using this product • Avoid getting into the eyes or on mucous membranes. • Do not apply to wounds or damaged skin. • Do not bandage tightly. • Do not use otherwise than as directed. Stop use and ask a doctor if Condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Centre right away. If pregnant or breast-feeding Ask a health professional before use.
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