Dorflex Icy Hot description, usages, side effects, indications, overdosage, supplying and lots more!

Dorflex Icy Hot

Lead Chemical Co. Ltd.
Lead Chemical Co. Ltd.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Dorflex Icy Hot Flexible Patch

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Principal Display Panel - Small
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

Principal Display Panel - Large
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

Principal Display Panel - Extra Large
Pouch Label - Extra Large

Dorflex Icy Hot

Menthol PATCH

Product Information

Product Type Human otc drug label Item Code (Source) NDC:62168-0085
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 205.5 mg

Inactive Ingredients

Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:62168-0085-1 5 in 1 POUCH
2 NDC:62168-0085-2 270 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2013-07-01


Dorflex Icy Hot

Menthol PATCH

Product Information

Product Type Human otc drug label Item Code (Source) NDC:62168-0086
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 428.5 mg

Inactive Ingredients

Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:62168-0086-3 5 in 1 POUCH
2 NDC:62168-0086-1 1 in 1 POUCH
3 NDC:62168-0086-2 540 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2013-07-01


Dorflex Icy Hot

Menthol PATCH

Product Information

Product Type Human otc drug label Item Code (Source) NDC:62168-0087
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 750 mg

Inactive Ingredients

Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:62168-0087-1 3 in 1 POUCH
2 NDC:62168-0087-2 120 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2013-07-01


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Be sure to consult your doctor before taking any medication!
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