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Dorflex Icy Hot Flexible, Small

Medically reviewed on July 23, 2018

Dosage form: patch
Ingredients: MENTHOL 205.5mg
Labeler: Lead Chemical Co. Ltd.
NDC Code: 62168-0085

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.

Dorflex Icy Hot® Flexible Patch

Active Ingredient

Menthol 5%

Purpose

Topical analgesic

Uses

Dorflex Icy Hot is indicated for bruises, traumas, muscle pains, cramps, torticollis and painful and inflammatory processes at large.

Warnings

For external use only

For use in adults and children over 12 years.

When using this product
  • Use only as directed.
  • Do not use with a heating pad.
  • Avoid contact with eyes and mucous membranes.
  • Do not apply to wounds or damaged, broken or irritated skin.

Stop use and ask a doctor if
  • Condition worsens.
  • Irritation or redness 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 doctor before use.

Keep out of reach of children.

If swallowed by accident, get medical help.

Directions
  • Remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
  • Carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • Once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area

Children 12 years or younger, ask a doctor

Precautions
  • Do not wear the same patch for more than 8 hours.
  • Do not wear more than 3 patches daily.
  • Store in ambient temperature.
  • Use each patch only once.

Inactive Ingredients

acrylic acid, aluminum hydroxide, carmellose sodium, 2-ethylhexyl acrylate, glycerin, isopropyl myristate, methyl acrylate, nonoxynol-30, polyacrylate, polyacrylic acid, polysorbate 80, sorbitan sesquioleate, starch, talc, tartaric acid, titanium dioxide, water

Other Information

Responsible pharmacist: Antonia A. Oliveira - CRF-SP 5.854. MS 8013490015

Manufactured by: Lead Chemical Company, Ltd., 77-3 Himata, Toyama City, 930-0912. Toyama, Japan. Packaged by: Chattem, Inc., 1715 West 38th Street, Chattanooga, Tennessee, 37409. United States. Imported by: Sanofi-Aventis Farmaceutica Ltda. Rua Conde domingos Papais, 413 - Suzano - SP - CEP 08613-010. CNPJ 02.685.377/0008-23.

Principal Display Panel - Small

Dorflex ICY HOT® Flexible Patch

  • Muscle pain
  • Bruises
  • Cramps
  • Torticollis
     

Lasts up to 8 hours

Contains 5 Patches in 1 Resealable Pouch

Cut open pouch and remove pad

Reseal pouch after opening

Pouch Label - Small

Principal Display Panel - Large

Dorflex ICY HOT® Flexible Patch

  • Muscle pain
  • Bruises
  • Cramps
  • Torticollis
     

Lasts up to 8 hours

Contains 5 Patches in 1 Resealable Pouch

Cut open pouch and remove pad

Reseal pouch after opening

Pouch Label - Large

Principal Display Panel - Extra Large

Dorflex ICY HOT® Flexible Patch

  • Muscle pain
  • Bruises
  • Cramps
  • Torticollis
     

Lasts up to 8 hours

Contains 3 Patches in 1 Resealable Pouch

Cut open pouch and remove pad

Reseal pouch after opening

Pouch Label - Extra Large

DORFLEX ICY HOT  FLEXIBLE, SMALL
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0085
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL205.5 mg
Inactive Ingredients
Ingredient NameStrength
ACRYLIC ACID 
ALUMINUM HYDROXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
2-ETHYLHEXYL ACRYLATE 
GLYCERIN 
ISOPROPYL MYRISTATE 
METHYL ACRYLATE 
NONOXYNOL-30 
SODIUM POLYACRYLATE (2500000 MW) 
POLYACRYLIC ACID (250000 MW) 
POLYSORBATE 80 
SORBITAN SESQUIOLEATE 
STARCH, CORN 
TALC 
TARTARIC ACID 
TITANIUM DIOXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:62168-0085-2270 POUCH in 1 BOX
1NDC:62168-0085-15 PATCH in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/2013
DORFLEX ICY HOT  FLEXIBLE, LARGE
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0086
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL428.5 mg
Inactive Ingredients
Ingredient NameStrength
ACRYLIC ACID 
ALUMINUM HYDROXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
2-ETHYLHEXYL ACRYLATE 
GLYCERIN 
ISOPROPYL MYRISTATE 
METHYL ACRYLATE 
NONOXYNOL-30 
POLYACRYLIC ACID (250000 MW) 
POLYSORBATE 80 
SODIUM POLYACRYLATE (2500000 MW) 
SORBITAN SESQUIOLEATE 
STARCH, CORN 
TALC 
TARTARIC ACID 
TITANIUM DIOXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:62168-0086-4135 POUCH in 1 BOX
1NDC:62168-0086-35 PATCH in 1 POUCH
2NDC:62168-0086-2540 POUCH in 1 BOX
2NDC:62168-0086-11 PATCH in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/2013
DORFLEX ICY HOT  FLEXIBLE, XL
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0087
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL750 mg
Inactive Ingredients
Ingredient NameStrength
ACRYLIC ACID 
ALUMINUM HYDROXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
2-ETHYLHEXYL ACRYLATE 
GLYCERIN 
ISOPROPYL MYRISTATE 
METHYL ACRYLATE 
NONOXYNOL-30 
POLYACRYLIC ACID (250000 MW) 
POLYSORBATE 80 
SODIUM POLYACRYLATE (2500000 MW) 
SORBITAN SESQUIOLEATE 
STARCH, CORN 
TALC 
TARTARIC ACID 
TITANIUM DIOXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:62168-0087-2120 POUCH in 1 BOX
1NDC:62168-0087-13 PATCH in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/2013
Labeler - Lead Chemical Co. Ltd. (693727091)
Registrant - Lead Chemical Co. Ltd. (693727091)
Establishment
NameAddressID/FEIOperations
Lead Chemical Co. Ltd.693727091ANALYSIS(62168-0085, 62168-0086, 62168-0087), MANUFACTURE(62168-0085, 62168-0086, 62168-0087)

 
Lead Chemical Co. Ltd.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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