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Name:Arthritis Hot
Manufacturer:Chattem, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Arthritis Hot

ARTHRITIS HOT - menthol and methyl salicylate cream 
Chattem, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Arthritis Hot

Drug Facts

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


ARTHRITIS HOT 
menthol and methyl salicylate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0600
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 10 g  in 100 g
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE 15 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
CETYL ESTERS WAX  
DIISOPROPYL ADIPATE  
OLETH-3 PHOSPHATE  
STEARIC ACID  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:41167-0600-2 1 TUBE (1 TUBE) in 1 CARTON contains a TUBE
1 85 g in 1 TUBE This package is contained within the CARTON (41167-0600-2)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 12/01/1998

Labeler - Chattem, Inc. (003336013)
Establishment
Name Address ID/FEI Operations
Chattem Plant 1 003336013 ANALYSIS, MANUFACTURE, PACK
Establishment
Name Address ID/FEI Operations
Chattem Plant 2 830410721 MANUFACTURE, PACK

Revised: 06/2011 Chattem, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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