Balsamo De Ubre
FDA Label NDC 53145-401

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Menper Distributors Inc. for the product Balsamo De Ubre (NDC 53145-401). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, uses, warnings, do not use    with a heating pad, stop use and ask a doctor immediately if, if pregnant or breast-feeding,, keep out of reach of children to avoid accidental poisoning., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Methyl Salicylate 10.5 % ............................................Topical Analgesic

Uses

Topical Analgesic

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains and sprains

Warnings

For external use only.

Avoid contact with the eyes.

Do not use otherwise than as directed

Do Not Use    With A Heating Pad

  • with a bandage
  • on wounds or dasmage skin
  • over extensive areas of the body
  • with a heating pad
  • on a child under 12 years of age
  • on irritated skin

Stop Use And Ask A Doctor Immediately If

  • pain persists for more than 7 days, redness is present, or in conditions affecting children under 12 years of age
  • excessive irritation of skin develops
  • condition worsens

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children To Avoid Accidental Poisoning.

If swallowed, induce vomiting and call a physician or contact a Poison Control Center right away.

Directions

  • Adults and Children 12 years and older: apply generously and gently massage into painful area until the product disappears. Apply into affected area not more than 3 to 4 times daily
  • Children under 12 years of age: ask a doctor

Other Information

Store at 15° C to 25° C (59° F to 77° F)

Inactive Ingrediets

camphor, D&C yellow #10, menthol, methylparaben, paraffin wax, propylparaben, white petrolatum.

Questions?

call 1-800-560-5223 M-F 9 AM to 4 PM Eastern

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