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Medicated Pain Relief Hot

Dosage form: patch
Ingredients: Menthol 29.44mg, CAPSICUM OLEORESIN 0.166mg
Labeler: Kareway Product, Inc.
NDC Code: 67510-0026

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.

Drug Facts

Active ingredients

L-Menthol 0.4%

Capsicum Extract (0.002% of Capsaicin)

Purposes

Topical analgesic

Topical analgesic

Uses

Temporarily relieves minor pain associated with:

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

Warnings

For external use only

When using this product
  • use only as directed
  • do not bandage tightly
  • do not use a heating pad
  • avoid contact with eyes and mucous membrane
  • do not apply to wounds or damaged skin
  • do not use if you are allergic to any ingredients of this product

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 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 12 years of age and older: Clean and dry affected area. Remove backing film and apply not more than 3 to 4 times daily.

Children under 12 years of age: Consult a physician.

Other informationstore at 20° to 25°C (68° to 77°F)

Inactive ingredients

Purified water, Glycerin, Disodium edetate, Tartaric acid, Gelatine, Polyvinyl alcohol, Sodium polyacrylate, Vitamin E acetate, Aloe vera

Package label

Pain Relief Hot Patch

MEDICATED PAIN RELIEF HOT 
menthol, capsicum extract patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0026
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol29.44 mg
CAPSICUM OLEORESIN (CAPSICUM OLEORESIN) CAPSICUM OLEORESIN0.166 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
EDETATE DISODIUM 
TARTARIC ACID 
GELATIN 
POLYVINYL ALCOHOL 
ALPHA-TOCOPHEROL ACETATE 
ALOE VERA LEAF 
Packaging
#Item CodePackage Description
1NDC:67510-0026-21 POUCH (POUCH) in 1 CARTON
12 PATCH (PATCH) in 1 POUCH
2NDC:67510-0026-41 POUCH (POUCH) in 1 CARTON
24 PATCH (PATCH) in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/16/2011
Labeler - Kareway Product, Inc. (121840057)

Revised: 09/2011
 
Kareway Product, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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