Quality Choice Ultra Strength Pain Relieving Cream
FDA Label NDC 63868-692

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Quality Choice (chain Drug Marketing Association) for the product Quality Choice Ultra Strength Pain Relieving Cream (NDC 63868-692). 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, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Camphor 4%

Menthol 10%

Methyl salicylate 30%

Purpose

Camphor - Topical analgesic

Menthol - Topical analgesic

Methyl salicylate - Topical analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises

Warnings

For external use only

When Using This Product

  • use only as directed
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop Use And Ask A Doctor If

  • skin redness or excessive irritation of the skin occurs
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Directions

  • adults and children 12 years and over; apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age; consult a physician

Inactive Ingredients

carbomer homopolymer type c, cetostearyl alcohol, cetyl alcohol, glyceryl monostearate, methylparaben, peg-100 stearate, polysorbate 60, propylparaben, stearic acid, trolamine, water

* Please review the disclaimer below.