Muscle Rub
FDA Label NDC 51852-105

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lifelabs, A Division Of Atico International Usa, Inc. for the product Muscle Rub (NDC 51852-105). 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 muscle rub (maximum strength), otc - purpose, warnings, indications & usage, storage and handling, dosage & administration, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Muscle Rub (Maximum Strength)

Active Ingredients

Methyl Salicylate - 30%, Menthol - 10%, Camphor - 4%

Otc - Purpose

Purpose

External Analgesic

Warnings

Warnings

For external use only. Use only as directed. Keep out of reach of children to avoid accidental poisoning.

  • avoid contact with eyes or mucous membranes.
  • discontinue use if excessive irritation of the skin develops.
  • do not bandage tightly, apply to wounds, or damaged skin, or use with a heating pad
  • if condition worsens, or if symptoms persist for more than 7 days or clear-up and occur again within a few days, consult a doctor
  • if skin redness or irritation develops, discontinue use of this product and consult a doctor.
  • if swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

Uses
  • For the temporary relief of minor aches and pains of muscles and joints.

Storage And Handling

Other Information

  • Store at controlled room temperature 15o to 30o C (59o to 86oF)
  • Lot No. and Exp. Date: see box or see crimp of tube

Dosage & Administration

Directions

  • Adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily
  • Children under 12 years of age: consult a doctor.

Inactive Ingredient

Inactive Ingredients

dea-cetyl phosphate, isopropyl myristate, glycerin, methylparaben, polysorbate 60, purefied lanolin, propylparaben, purified water, sorbitan monostearate, stearyl alcohol, white petrolatum

Otc - Questions

Questions? Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.

Package Label.Principal Display Panel


Otc - Keep Out Of Reach Of Children

Keep out of reach of children to avoid accidental poisoning.

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