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Cold and Hot Medicated Pain Relief Large

Dosage form: patch
Ingredients: MENTHOL 875mg
Labeler: Valu Merchandisers Company, Inc.
NDC Code: 63941-949

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

UsesTemporarily relieves minor pain associated with:
  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • muscle sprains
  • bruises
  • cramps

Warnings

For external use only

When using this product
  • use only as directed
  • do not bandage tightly or use with heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin

Stop use and ask a doctor if
  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding,ask a health professional before use.

Keep out of reach of children.

For use on children 12 years or younger consult a doctor. Do not use on infants. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions Adults and children over 12 years:
  • carefully remove backing from patch
  • apply sticky side of patch to affected area
  • repeat as necessary, but no more than 4 times daily

Inactive ingredients

2-ethylhexyl acrylate, acrylic acid, aluminium hydroxide, carboxymethylcellulose sodium, glycerin, isopropyl myristate, methyl acrylate, nonoxynol-30, polyacrylic acid, polysorbate 80, purified water, sodium polyacrylate, sorbitan sesquioleate, starch, talc, tartaric acid, titanium oxide

package label
Best Choice Cold and Hot Large Medicated Patch

COLD AND HOT MEDICATED PAIN RELIEF LARGE 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-949
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL875 mg
Inactive Ingredients
Ingredient NameStrength
ACRYLIC ACID 
ALUMINUM HYDROXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
GLYCERIN 
ISOPROPYL MYRISTATE 
METHYL ACRYLATE 
NONOXYNOL-30 
POLYSORBATE 80 
WATER 
SORBITAN SESQUIOLEATE 
TALC 
TARTARIC ACID 
TITANIUM DIOXIDE 
Packaging
#Item CodePackage Description
1NDC:63941-949-051 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 - Valu Merchandisers Company, Inc. (868703513)

Revised: 09/2011
Document Id: ec9e844d-0b99-417f-9b41-acaaeab36fe8
Set id: b7ad84f8-e3e0-47a3-ace2-463ecbdfee3e
Version: 1
Effective Time: 20110912
 
Valu Merchandisers Company, 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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