Myoflex
FDA Label NDC 55741-304

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dr. Reddy's Laboratories Inc. for the product Myoflex (NDC 55741-304). 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 other, active ingredient, purpose, use, warnings, do not use, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

Active Ingredient

Trolamine salicylate 10%

Purpose

Pain relieving cream

Use

  • temporarily relieves minor aches and pains of muscles and joints due to arthritis, strains and sprains, and simple backache

Warnings

For external use only

Do Not Use

  • in or near eyes
  • on wounds or damaged skin

Stop Use And Ask A Doctor If

  • condition lasts or gets worse
  • symptoms last more than 7 days or clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding

If you are pregnant or breast-feeding, ask a health care professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

  • do not use more than directed
  • adults and children 2 years and older
    • apply to affected area not more than three to four times a day
    • may be covered with a sterile bandage
    • children under 2 years: ask a doctor

Other Information

  • store at controlled room temperature 20-25°C (68-77°F)
  • close cap tightly

Inactive Ingredients

aloe vera gel, cetyl alcohol, glycerin, DMDM hydantoin, methylparaben, propylparaben, mineral oil, stearic acid, triethanolamine, purified water

Questions?

call 1-800-790-6417

Principal Display Panel - 113 G Tube Box

NDC 55741-304-04

up to 8 - Hour Formula

MYOFLEX®
PAIN RELIEVING CREAM

TROLAMINE SALICYLATE 10%

Targeted Relief From Minor Backache, Arthritis, Muscle & Joint Pain

✓ Deep Penetrating      ✓ Odorless      ✓ Pharmacist Recommended

NET WT. 4 oz (113 g)

Principal Display Panel (113 g Tube Box)

Principal Display Panel (113 g Tube Box)

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