Motto
FDA Label NDC 53093-433

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Motto-elektro Ltd. for the product Motto (NDC 53093-433). 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 purpose, active ingredient, warnings, keep out of reach of children, directions, dosage, inactive ingredient, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Purpose

external analgesic

Uses

Releives chronic and acute pain of muscles and joints due to:

  • rheumatic complaints
  • lumbago
  • headache
  • tennis elbow
  • menstrual pain

Active Ingredient

sulfur 9 mg

Warnings

For external use only

If pregnant or breast-feeding, ask a health professional before use

Allergy alert:

This product contains natural rubber latex which may cause allergic reactions.

Do not use

  • on wounds
  • on irritated or damaged skin
  • with a heating pad
  • otherwise than as directed

    • Stop use and ask a doctor if

    • excessive irritation of the skin develops
    • condition worsens
    • skin rush occurs

Keep Out Of Reach Of Children

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

Directions

Clean the affected area. Remove the silikon paper film from the patch.

Dosage

  • adults and children 12 years of age and older: cut up a patch into pieces of desired sizes and apply to affected area. Use up to 10 days.
  • children under 12 years of age: do not use, consult your physician
  • use according to the User Guide inside the package
  • refer to the above warnings; use otherwise than as directed may be dangerous

    • Other information

    Store at room temperature 15° to 30°C (59° to 86°F), away from sunlight.

Inactive Ingredient

zinc oxide, on an adhesive bandage backing with a protective paper

Questions Or Comments?

Ph. 1-888-477-5374 M-F 9 am to 5 pm

You may also report serious side effects to this phone number.

Motto Analgesic Patch Package

Analgesic_package.jpg (Analgesic Package)

Analgesic_package.jpg (Analgesic Package)

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