COLD AND HOT MEDICATED PAIN RELIEF SMALL - 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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Drug Facts

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

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:

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 Small Medicated Patch
image of carton label
COLD AND HOT MEDICATED PAIN RELIEF SMALL 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-950
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL400 mg
Inactive Ingredients
Ingredient NameStrength
ACRYLIC ACID (UNII: J94PBK7X8S)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYL ACRYLATE (UNII: WC487PR91H)  
NONOXYNOL-30 (UNII: JJX07DG188)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
TALC (UNII: 7SEV7J4R1U)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63941-950-051 in 1 CARTON
15 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: 9/2011
Document Id: ff0871b2-0363-463a-bf7e-7399370fd32d
Set id: 75bc6993-cd63-4eba-bdb9-5c5370cc951c
Version: 1
Effective Time: 20110912
 
Valu Merchandisers Company, Inc.