Muscle Rub
FDA Label NDC 61767-406

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Blossom Pharmaceuticals for the product Muscle Rub (NDC 61767-406). 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, indications and usage, warnings, stop use, keep out of reach of children, dosage & administration, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Active Ingredient                                  Purpose

Natural Menthol USP 10%                     Topical analgesic

Methyl salicylate  30%                           Topical analgesic

Camphor 4%                                         Topical analgesic                                 

Purpose

Temporary relief of minor aches and pains.

Indications And Usage

Uses

Temporary relief of minor aches and pains of sore muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Warnings

For external use only.

  • Avoid contact with the eyes or mucous membranes.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.
  • Do not use with heating pad or device.

Stop Use

Stop Use And Ask A Doctor If:

  • Condition worsens, or if symptoms persist for more than 7 days,
  • symptoms clear up and occur again in a few days
  • redness is present or excessive skin irritation develops

    • If pregnant or breast feeding:

    Ask a health professional before use.

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Dosage & Administration

Directions

  • Use only as directed
  • Adults and children 12 years of age and older: apply to the affected areas not more than 3 or 4 times daily.
  • Children under 12 years of age: Consult a physician.

Other Information

Store at 20° - 25°C (68°-77°F)

Inactive Ingredients

Acrylates/C-10-30 alkyl acrylates, benzyl alcohol, carbomer, polysorbate 80, trolamine, water.

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Blossom Pharmaceuticals Muscle Rub

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