COLD AND HOT MEDICATED PAIN RELIEF LARGE- menthol patch 
Valu Merchandisers Company, Inc.

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.

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Best Choice Cold & Hot Large Medicated Patch

Active Ingredient

Menthol 5%

Purpose

Topical analgesic

Uses

Temporarily relieves minor pain associated with:

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
  • 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 immediately.

Directions

Adults and children over 12 years:

Children under 12 years of age: Ask a doctor

Inactive ingredients

dihydroxyaluminum aminoacetate, glycerin, kaolin, methylparaben, polyacrylic acid, polyethylene glycol 400, polysorbate 80, povidone, propylparaben, purified water, sodium polyacrylate, tartaric acid, titanium dioxide

Questions or Comments?

call 1-800-883-0085

Reseal pouch after opening

package label


Best Choice Cold and Hot Large Medicated Patch

carton

COLD AND HOT MEDICATED PAIN RELIEF LARGE 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-949
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL875 mg
Inactive Ingredients
Ingredient NameStrength
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
POVIDONE (UNII: FZ989GH94E)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAOLIN (UNII: 24H4NWX5CO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63941-949-051 in 1 CARTON12/29/2018
15 in 1 POUCH; Type 0: Not a Combination Product
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: 3/2019
Document Id: 838a5a74-d46c-d6d1-e053-2a91aa0aa512
Set id: b7ad84f8-e3e0-47a3-ace2-463ecbdfee3e
Version: 4
Effective Time: 20190307
 
Valu Merchandisers Company, Inc.