Pain Relief Rub
FDA Label NDC 36800-042

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Pain Relief Rub (NDC 36800-042). 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 ingredients, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, keep out of reach of children to avoid accidental ingestion., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients


Camphor 4%

Menthol 10%

Methyl Salicylate 30%


Uses

temporarily relieves the minor aches and pains of muscle and joints associated with: simple backache, arthritis, bruises, sprains

Warnings

For external use only.

Do Not Use

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Ask A Doctor Before Use If You Have

redness over the affected area

When Using This Product

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop Use And Ask A Doctor If

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Keep Out Of Reach Of Children To Avoid Accidental Ingestion.

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

  • Use only as directed
  • adults and children 12 years of age and older:
    •              apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age:  ask a doctor

Other Information

  • Store at 20° to 25°C (68°to 77°F)

Inactive Ingredients

carbomer940, cetyl alcohol, glyceryl monostearate, isopropyl myristate, polysorbate60, purified water, stearic acid, trolamine

Package Label.Principal Display Panel

Pain Relief Rub

Image Of Carton Label (Muscleultra)

Image Of Carton Label (Muscleultra)

Otc - Purpose

Topical analgesic

Topical analgesic

Topical analgesic

* Please review the disclaimer below.