Muscle Rub Ultra
FDA Label NDC 51141-0659

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Neopharm Co., Ltd. for the product Muscle Rub Ultra (NDC 51141-0659). 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 bachache
  • arthritis
  • strains
  • 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

carbomer, edetate disodium, glyceryl stearate se, lanolin, polysorbate 80, potassium hydroxide, purified water, stearic acid, trolamine

Questions?

call 1-800-883-0085, weekdays, 9AM -5PM PST

Package Label.Principal Display Panel

Muscle Rub Ultra

Image Of Carton Label (Ultra.carton)

Image Of Carton Label (Ultra.carton)

Otc - Purpose

Topical analgesic

Topical analgesic

Topical analgesic

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