DORFLEX ICY HOT FLEXIBLE, SMALL- menthol patch DORFLEX ICY HOT FLEXIBLE, LARGE- menthol patch DORFLEX ICY HOT FLEXIBLE, XL- menthol patch

Dorflex Icy Hot by

Drug Labeling and Warnings

Dorflex Icy Hot by is a Otc medication manufactured, distributed, or labeled by Lead Chemical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
Dorflex icy hot is a flexible adhesive that provides cooling relief

Contains 5 Patches in 1 Resealable Pouch

Cut open pouch and remove pad

Reseal pouch after opening

Pouch Label – Large

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

INGREDIENTS AND APPEARANCE

DORFLEX ICY HOT  FLEXIBLE, SMALL
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62168-0085
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	205.5 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62168-0085-2	270 in 1 BOX	07/01/2013
1	NDC: 62168-0085-1	5 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/01/2013

DORFLEX ICY HOT  FLEXIBLE, LARGE
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62168-0086
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	428.5 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62168-0086-4	135 in 1 BOX	07/01/2013	07/23/2020
1	NDC: 62168-0086-3	5 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 62168-0086-2	540 in 1 BOX	07/01/2013	03/01/2018
2	NDC: 62168-0086-1	1 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 62168-0086-5	100 in 1 BOX	08/24/2017
3		5 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/01/2013

DORFLEX ICY HOT  FLEXIBLE, XL
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62168-0087
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	750 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62168-0087-2	120 in 1 BOX	07/01/2013	10/24/2019
1	NDC: 62168-0087-1	3 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/01/2013	10/24/2019

Labeler - Lead Chemical Co. Ltd. (693727091)

Registrant - Lead Chemical Co. Ltd. (693727091)

Establishment
Name	Address	ID/FEI	Business Operations
Lead Chemical Co. Ltd.		693727091	ANALYSIS(62168-0085, 62168-0086, 62168-0087) , MANUFACTURE(62168-0085, 62168-0086, 62168-0087)