Dynarex Muscle Rub Cream
FDA Label NDC 67777-416

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Dynarex Muscle Rub Cream (NDC 67777-416). 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

Menthol 10%                                        Topical analgesic

Methyl salicylate  15%  w/w                         Topical analgesic

Purpose

Temporary relief of minor aches and pains of muscle joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

    • Do not use other than directed.

Indications And Usage

Uses

Temporary relief of minor aches and pains of sore muscles and joints.

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

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

Allantoin, carbomer, cetyl alcohol, dimethicone, disodium EDTA, glycerin, glyceral monostearate, isopropyl myristate, methyparaben, phenoxyethanol, potassium cetyl phoshate, propylparaben, purified water, sodium hydroxide, stearic acid, titanium dioxide, polysorbate 20, Vitamin E, xanthan gum.

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