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Eagle brand medicated roll on refresh - Medication Information

Product NDC Code 43405-012
Drug Name

Eagle brand medicated roll on refresh

Type Brand
Active Ingredients
Camphor (synthetic) 2.2 g/100ml
Menthol 14 g/100ml
Route TOPICAL
Dosage Form OIL
RxCUI drug identifier 2672336
Application Number M017
Labeler Name Borden Company (Private) Limited
Packages
Package NDC Code Description
43405-012-08 1 bottle, glass in 1 box (43405-012-08) / 8 ml in 1 bottle, glass
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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 CLOVE OIL BETA CAROTENE D&C RED NO. 17 LIGHT MINERAL OIL CAMPHOR (SYNTHETIC) CAMPHOR (SYNTHETIC) MENTHOL MENTHOL PEPPERMINT 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: 43405-012-08 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 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 feeding
If 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 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