HOT/COLD MEDICATED PATCH- hot cold patch patch 
Dynarex

----------

1451 Cold/Hot Medictaed Patches Arm/Neck 67777-201-10
1452 Cold/Hot Medicated Patches Back 67777-201-20

Active Ingredient

Menthol 5%

Purpose

Topical analgesic

Use

Temporarily relieves minor aches and pains of muscles and joints due to

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 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

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children 12 years of age and over

Children under 12 years of age, consult a doctor

Other information

Inactive ingredients

Aluminum Hydroxide, Castor Oil, Disodium EDTA, Glycerin, Isopropyl Myristate, Kaolin, Polysorbate 80, Polyvinyl Alcohol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Questions and Comments?

1-888-396-2739 Monday - Friday 9AM - 5PM EST

Label

1451 IN MASTER1451 Hot Cold Medicated Patch

Label

1452 IN MASTER1452 Hot Cold Medicated Patch

HOT/COLD MEDICATED PATCH 
hot cold patch patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL285 mg  in 5700 mg
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CASTOR OIL (UNII: D5340Y2I9G)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAOLIN (UNII: 24H4NWX5CO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-201-10180 in 1 CASE12/13/2019
1NDC:67777-201-115 in 1 BOX
1285 mg in 1 PATCH; Type 0: Not a Combination Product
2NDC:67777-201-20180 in 1 CASE12/13/2019
2NDC:67777-201-215 in 1 BOX
2285 mg in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01712/13/2019
Labeler - Dynarex (008124539)
Registrant - Dynarex (008124539)

Revised: 12/2023
Document Id: 0d81c27e-2bbb-2fb2-e063-6294a90abd15
Set id: 999881b3-287e-d975-e053-2995a90a87e3
Version: 4
Effective Time: 20231227
 
Dynarex