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Medicated Pain Relief by Kareway Product, Inc.

Medically reviewed on September 12, 2018

Dosage form: patch
Ingredients: MENTHOL 428.5mg
Labeler: Kareway Product, Inc.
NDC Code: 67510-0301

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 IngredientL-Menthol 5%

PurposeTopical analgesic

UsesTemporarily relieves minor arthritis pain, simple backache, bursitis tendonitis, muscle strains and sprains, bruises and cramps.

Warnings

For external use only

When using this product
  • use only as directed
  • do not bandage tightly or use a heating pad
  • avoid contact with eyes and mucous membrane
  • do not apply to wounds or damaged 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 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:
  • Carefully remove backing from patch
  • Apply one patch to affected area
  • Repeat as necessary, but no more than 4 times daily.
Children 12 years or younger: ask a doctor

Inactive ingredients

Purified Water, Acrylic Acid, Aluminum Hydroxide, Carboxymethylcellulose sodium, 2-Ethylhexyl Acrylate, Glycerin, Isopropyl Myristate, Methyl Acrylate, Nonoxymol-30, Sodium Polyacrylate, Polyacrylic Acid, Polysorbate 80, Sorbitan Sesquioleate, Starch, Talc, Tartaric acid, Titanium Dioxide

package label
Pain Relief Medicated Patch
MEDICATED PAIN RELIEF 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0301
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL428.5 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
ACRYLIC ACID 
ALUMINUM HYDROXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
GLYCERIN 
ISOPROPYL MYRISTATE 
METHYL ACRYLATE 
NONOXYNOL-30 
POLYSORBATE 80 
SORBITAN SESQUIOLEATE 
TALC 
TARTARIC ACID 
TITANIUM DIOXIDE 
Packaging
#Item CodePackage Description
1NDC:67510-0301-51 POUCH (POUCH) in 1 CARTON
15 PATCH (PATCH) in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/12/2011
Labeler - Kareway Product, Inc. (121840057)

 
Kareway Product, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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