Arthritis Hot Cream
FDA Label NDC 41167-0600

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Arthritis Hot (NDC 41167-0600). 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, purpose, uses, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Menthol 10%

Methyl salicylate 15%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When Using This Product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

If Pregnant Or Breast-Feeding,

ask a health care professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children over 12 years:

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 3 to 4 times daily

    • children 12 years or younger: ask a doctor

Inactive Ingredients

carbomer, cetyl esters, diisopropyl adipate, emulsifying wax, oleth-3 phosphate, stearic acid, triethanolamine, water (283-085)

Principal Display Panel

ARTHRITIS HOT
deep penetrating Pain Relief Crème
NET WT 3 OZ (85g)

Principal Display Panelarthritis Hotdeep Penetrating Pain Relief Crèmenet Wt 3 Oz (85g) (Arthritis Hot 01)

Principal Display Panelarthritis Hotdeep Penetrating Pain Relief Crèmenet Wt 3 Oz (85g) (Arthritis Hot 01)

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