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Cold and Hot Pain Relief Sleeve

Dosage form: patch
Ingredients: MENTHOL 400mg
Labeler: Kareway Product, Inc.
NDC Code: 67510-0085

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 ingredient

Menthol 16%

Purpose

Topical analgesic

Uses

Temporarily relieves minor pain associated with arthritis, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps.

Warnings

For external use only

When using this product
  • use only as directed
  • do not bandage tightly or use with 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

  • Clean and dry affected area.
  • Cut open pouch and remove Sleeve.
  • Remove the clear plastic insert.
  • Pull Sleeve onto knee, large ankle or elbow.
  • Medication is on the colored section of the Sleeve, so the colored section should be placed on the affected area.
  • Pull Sleeve over itself to make medicine touch directly on your skin.
  • Apply one Sleeve to affected area.
  • Repeat as necessary , but no more than 4 times a day.
  • Sleeve should fit snug, but not tight.
Children 12 years or younger: ask a doctor

Inactive ingredients

Glycerin, Hydroxyethylcellulose, Isopropyl Alcohol, Polysorbate 80, Methylparaben, Propylparaben, Purified Water

Package label

COLD AND HOT PAIN RELIEF SLEEVE 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0085
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL400 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
ISOPROPYL ALCOHOL 
POLYSORBATE 80 
METHYLPARABEN 
PROPYLPARABEN 
WATER 
Packaging
#Item CodePackage Description
1NDC:67510-0085-41 POUCH (POUCH) in 1 BOX
11 PATCH (PATCH) in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/19/2012
Labeler - Kareway Product, Inc. (121840057)

Revised: 04/2012
Document Id: 812af3dc-733f-4833-bb37-c7fab12e8827
Set id: 1a11d455-c8e5-4ee7-8e0b-6c3eefc29c86
Version: 1
Effective Time: 20120419
 
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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