COLD/HOT MEDICATED PATCHES- medicated patches patch 
Dynarex Corporation

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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1451 - NDC 67777-145-10
1452 - NDC 67777-145-20
1453 - NDC 67777-145-30

Active ingredient

Menthol 5%

Purpose

Topical analgesic

Use

Temporarily relieves minor aches and pains of muscles and joints due to arthritis, simple backache, strains, sprains, bruises

Warnings

For external use only

Do not use

on wounds or damaged skin, with a heating pad, if you are allergic to any ingredients of this product

When using this product

use only as directed, avoid contact with the eyes, mucous membranes or rashes

Stop use and ask a doctor if

  • excessive redness or irritation is present
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

If pregnant or breast-feeding,

ask a health professional before use.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and over

Children under 12 years of age

Other information

Inactive ingredients

Aluminum Hydroxide, Castor Oil, Disodium EDTA, Glycerin, Isopropyl Myristate, Kaolin, Polysorbate, Polyvinyl Alcohol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

Label NDC 67777-145-10

NDC 67777-145-10

Label NDC 67777-145-20

NDC 67777-145-20

Label NDC 67777-145-30

NDC 67777-145-30

COLD/HOT MEDICATED PATCHES 
medicated patches patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-145
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 5 mg
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TARTARIC ACID (UNII: W4888I119H)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
CASTOR OIL (UNII: D5340Y2I9G)  
KAOLIN (UNII: 24H4NWX5CO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-145-10180 in 1 CASE08/15/2018
15 in 1 BOX
15 mg in 1 PATCH; Type 0: Not a Combination Product
2NDC:67777-145-20180 in 1 CASE08/15/2018
25 in 1 BOX
25 mg in 1 PATCH; Type 0: Not a Combination Product
3NDC:67777-145-30108 in 1 CASE08/15/2018
33 in 1 BOX
35 mg in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/15/2018
Labeler - Dynarex Corporation (008124539)

Revised: 11/2018
Document Id: 7a1449c9-7a45-412d-e053-2991aa0a6649
Set id: 7a1449c9-7a44-412d-e053-2991aa0a6649
Version: 1
Effective Time: 20181107
 
Dynarex Corporation