COLD AND HOT PAIN RELIEF - menthol patch 
Navarro Discount Pharmacies,LLC

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
  • do not use a heating pad
  • avoid contact with eyes and mucous membrane
  • 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 right away.

Directions

Adults and children over 12 years:

Children under 12 years of age: Ask a doctor

Other information

store at room temperature

Inactive ingredients

aluminium glycinate, 1,3-butylene Glycol, carboxymethylcellulose Sodium, concentrated Glycerin, diethylene glycolmonoethyl Ether, disodium edetate, methyl parahydroxybenzoate, polyacrylic acid solution, polysorbate 80, propyl parahydroxybenzoate, purified water, sodium polyacrylate, tartaric acid, titanium dioxide

package label


Cold and Hot Pain Relief Patchimage of carton label

COLD AND HOT PAIN RELIEF 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59970-080
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL400 mg
Inactive Ingredients
Ingredient NameStrength
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59970-080-051 in 1 CARTON
15 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/15/2012
Labeler - Navarro Discount Pharmacies,LLC (094930963)

Revised: 9/2011
Document Id: fee95a7c-9b47-444d-b232-82d4c4a14f52
Set id: cbedf6d3-629b-4f8c-a761-c9402ea4765d
Version: 1
Effective Time: 20110912
 
Navarro Discount Pharmacies,LLC