Med Rub Balm Ointment
FDA Label NDC 85278-251

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Wellmetech Pharmaceutical Industries Sdn Bhd for the product Med Rub Balm (NDC 85278-251). 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, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Camphor  5%

Menthol  10%

Methyl Salicylate  23.5%

Purpose

Menthol       External Analgesic
Camphor           External Analgesic
Methyl Salicylate        External Analgesic

Uses

  Temporary relief of minor aches and pains of muscle and joint due to:

  • Simple backache arthritis
  • Arthritis
  • Muscle strains
  • Sprains
  • Bruises

Warnings

For external use only.

When Using This Product

  • Use only as directed.
  • Avoid contact with eyes and mucous membranes.
  • Do not bandage tightly.
  • Do not use on wounds or damaged skin or with heat source.

Stop Use And Ask A Doctor If

  • Condition worse.
  • Severe skin irritation occurs.
  • Symptoms persist for more than 7 days.
  • Symptoms clear up and occur again within a few days.

Keep Out Of Reach Of Children

  • If swallowed, get medical help or contact a Poison Control Center right away.
  • If pregnant or breastfeeding, ask a health professional before use.

Directions

  • Adult and chldren over 2 years old, rub well on the affected area not more than 3-4 times a day.
  • For children under 2 years old, consult a doctor before use.

Storage And Handling

Keep container tightly closed at 30°C (86°F).

Inactive Ingredient

Paraffin, Microcrystalline Wax, Eucalyptus Globulus Oil, Nutmeg Oil

Manufacturer:

Wellmetech Pharmaceutical Industries Sdn. Bhd.
Lot 8058, Kota Samarahan Industrial Park, 94300 Samarahan, Malaysia

Imported By

Edmark USA, INC
1175-147th Ave, Wayland, MI 49348
[email protected]

Product of Malaysia

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