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Electric medicated balm - Medication Information

Product NDC Code 63299-046
Drug Name

Electric medicated balm

Type Brand
Active Ingredients
Menthol 11 g/100g
Methyl salicylate 22 g/100g
Route TOPICAL
Dosage Form OINTMENT
RxCUI drug identifier 2261404
Application Number part348
Labeler Name FEI FAH MEDICAL MANUFACTURING PTE LTD
Packages
Package NDC Code Description
63299-046-01 1 jar in 1 box (63299-046-01) / 19 g in 1 jar
63299-046-04 1 jar in 1 box (63299-046-04) / 70 g in 1 jar
63299-046-05 1 jar in 1 box (63299-046-05) / 10 g in 1 jar
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Menthol 11% Methyl salicylate 22%

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 3 years of age and older: Apply a small amount with your finger tip then gently rub into the affected area not more than 3 to 4 times daily. Children under 3 years of age: Do not use, consult your doctor.

Inactive ingredient

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

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 due to simple backache arthritis strains bruises sprains

Purpose

Information about the drug product’s indications for use.
Purpose External analgesic External analgesic

Spl product data elements

Usually a list of ingredients in a drug product.
ELECTRIC MEDICATED BALM Menthol and Methyl Salicylate MENTHOL MENTHOL METHYL SALICYLATE SALICYLIC ACID PETROLATUM

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.
ELECTRIC MEDICATED BALM External Analgesic NDC 63299-046-04 NET 2.45 oz (70g) IMAGE OF 70G BOX

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 on irritated or damaged skin on the face otherwise than as directed

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 to avoid accidental poisoning If swallowed, get medical help or contact a Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? (888) 221-3496 M-F 9am to 5pm you may also report serious side effects to this phone number

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 symptoms persist for more than 7 days symptoms clear up and occur again within a few days excessive irritation of the skin develops nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs when using for pain of arthritis pain persists for more than 10 days redness is present in conditions affecting children under 12 years of age

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 contact with the eyes or mucous membranes do not bandage tightly

Storage and handling

Information about safe storage and handling of the drug product.
Other information keep container tightly closed store at 15° to 30°C (59° to 86°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

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