HOT/COLD MEDICATED PATCH- hot cold patch patch 
Dynarex

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 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

  • 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 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

  • Clean and dry affected area
  • Remove film from patch and apply to the skin
  • Apply 1 patch at a time to affected area,not more than 3 to 4 times daily
  • Wear each patch up to 8 hours maximum

Children under 12 years of age, consult a doctor

Other information

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

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)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
GLYCERIN (UNII: PDC6A3C0OX)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
KAOLIN (UNII: 24H4NWX5CO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-201-10180 in 1 CASE12/13/2019
15 in 1 BOX
1285 mg in 1 PATCH; Type 0: Not a Combination Product
2NDC:67777-201-20180 in 1 CASE12/13/2019
25 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 not finalpart34812/13/2019
Labeler - Dynarex (008124539)
Registrant - Dynarex (008124539)

Revised: 5/2022
Document Id: dfea53f8-5c5f-36df-e053-2a95a90a445c
Set id: 999881b3-287e-d975-e053-2995a90a87e3
Version: 2
Effective Time: 20220526
 
Dynarex