DORFLEX ICY HOT FLEXIBLE, SMALL- menthol patch 
DORFLEX ICY HOT FLEXIBLE, LARGE- menthol patch 
Lead Chemical Co., Ltd.

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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: Mauricio R. Marante - CRF-SP 28.847. ANVISA Registration No. 81807850002

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 Medley Farmaceutica Ltda. Rua Conde domingos Papaiz, 413 - Suzano - SP - CEP 08613- 901. CNPJ 10.588.595/0010-92.

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

image-01

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

image-03

Pouch Label - Large

DORFLEX ICY HOT  FLEXIBLE, SMALL
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0085
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL205.5 mg
Inactive Ingredients
Ingredient NameStrength
ACRYLIC ACID (UNII: J94PBK7X8S)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYL ACRYLATE (UNII: WC487PR91H)  
NONOXYNOL-30 (UNII: JJX07DG188)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62168-0085-3270 in 1 BOX04/22/202110/31/2024
15 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)07/01/201310/31/2024
DORFLEX ICY HOT  FLEXIBLE, LARGE
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62168-0086
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL428.5 mg
Inactive Ingredients
Ingredient NameStrength
ACRYLIC ACID (UNII: J94PBK7X8S)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYL ACRYLATE (UNII: WC487PR91H)  
NONOXYNOL-30 (UNII: JJX07DG188)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62168-0086-6100 in 1 BOX09/20/202011/30/2024
15 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)07/01/201311/30/2024
Labeler - Lead Chemical Co., Ltd. (693727091)

Revised: 1/2024
Document Id: c9cb8c59-1b93-4fa8-88dc-c2dc434b2f8f
Set id: 3d69bc86-aa79-4f06-ab39-59aa41f82b54
Version: 6
Effective Time: 20240125
 
Lead Chemical Co., Ltd.