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Medicated Pain Relief by Kareway Product, Inc.

Medically reviewed on September 7, 2017

Dosage form: patch
Ingredients: MENTHOL 428.5mg
Labeler: Kareway Product, Inc.
NDC Code: 67510-0302

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 IngredientMenthol 5%

PurposeTopical analgesic

Uses
  • temporarily relieves minor aches and pains of muscles and joints associated with:
    • simple backache
    • arthritis
    • bruises
    • sprains

Warnings

For external use only

Do not use
  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

Ask a doctor before using if you have
  • redness over the affected area

When using this product
  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop use and ask a doctor if
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Keep out of reach of children.

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

Directions
  • open pouch and remove patch
  • if desired, cut patch to size
  • peel off protective backing and apply sticky side to affected area
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a doctor

Other information
  • store at 20° to 25°C (68°F to 77°F)


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 Relieving Patch, 4pk



Bulk Patch

MEDICATED PAIN RELIEF 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0302
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:67510-0302-44 POUCH (POUCH) in 1 CARTON
11 PATCH (PATCH) in 1 POUCH
2NDC:67510-0302-11 PATCH (PATCH) in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/07/2011
Labeler - Kareway Product, Inc. (121840057)

 
Kareway Product, Inc.

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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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