Indications and uses
Dorflex Icy Hot is indicated for bruises, traumas, muscle pains, cramps, torticollis and painful and inflammatory processes at large.
Dorflex Icy Hot ® Flexible Patch
- Manufacturer
- Lead Chemical Co., Ltd.
- Effective date
- 2024-01-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:12:14
Label at a glance#
ProductDorflex Icy Hot Flexible, Small
Active ingredientMENTHOL
Label structure10 sections
Dosage and administration
• 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
Label 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: 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
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
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | 1 | |
| 2-ETHYLHEXYL ACRYLATE | INACTIVE INGREDIENT | HR49R9S6XG | 1 | |
| ACRYLIC ACID | INACTIVE INGREDIENT | J94PBK7X8S | 1 | |
| ALUMINUM HYDROXIDE | INACTIVE INGREDIENT | 5QB0T2IUN0 | 1 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | 1 | |
| METHYL ACRYLATE | INACTIVE INGREDIENT | WC487PR91H | 1 | |
| NONOXYNOL-30 | INACTIVE INGREDIENT | JJX07DG188 | 1 | |
| POLYACRYLIC ACID (250000 MW) | INACTIVE INGREDIENT | 9G2MAD7J6W | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 1 | |
| SODIUM POLYACRYLATE (2500000 MW) | INACTIVE INGREDIENT | 05I15JNI2J | 1 | |
| SORBITAN SESQUIOLEATE | INACTIVE INGREDIENT | 0W8RRI5W5A | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 1 | |
| TARTARIC ACID | INACTIVE INGREDIENT | W4888I119H | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Dorflex Icy Hot Flexible, Small
- Menthol
- ACRYLIC ACID
- ALUMINUM HYDROXIDE
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- 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
- Dorflex Icy Hot Flexible, Large
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 62168-0085 | 62168-0085-3 |
| 62168-0086 | 62168-0086-6 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRAMUSCULAR | 4 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION / RESPIRATORY (INHALATION) | 1 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | FILM, EXTENDED RELEASE / TRANSDERMAL | 20.4 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY / VAGINAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SYSTEM / TOPICAL | 420 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET, COATED / ORAL | 3.2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION / ORAL | 206 mg | ||
| TALC | TALC | 7SEV7J4R1U | OINTMENT / TOPICAL | 74.6 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL / TOPICAL | 29 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SOLUTION / OPHTHALMIC | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, EXTENDED RELEASE / ORAL | 300 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / AURICULAR (OTIC) | 0.2 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRALESIONAL | 4 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | LIQUID / INTRAVENOUS | 720 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| ALUMINUM HYDROXIDE | ALUMINUM HYDROXIDE | 5QB0T2IUN0 | TABLET / ORAL | 50 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | INSERT / VAGINAL | 147 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, CHEWABLE / ORAL | 84 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUPPOSITORY / VAGINAL | 28 mg | ||
| TARTARIC ACID | TARTARIC ACID | W4888I119H | INJECTION / INTRAVENOUS | 20 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRA-ARTICULAR | 4 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRASYNOVIAL | 0.2 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | FILM / TRANSDERMAL | 58.08 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | POWDER, FOR SOLUTION / ORAL | 161 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION / SUBCUTANEOUS | 0.3 %w/v | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 357 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC | 0.05 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 20 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, COATED / ORAL | 320.75 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION, EXTENDED RELEASE / ORAL | 113 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| TALC | TALC | 7SEV7J4R1U | LOZENGE / ORAL | 50 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION/ DROPS / ORAL | 90 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 8 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | GEL / TOPICAL | 12 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | EMULSION / OPHTHALMIC | 26 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SUSPENSION / ORAL | 1080 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, DELAYED RELEASE / ORAL | 4 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | PASTE / ORAL | 28 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CONCENTRATE / INTRAVENOUS | 4680 mg | ||
| TARTARIC ACID | TARTARIC ACID | W4888I119H | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 11 mg |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| c9cb8c59-1b93-4fa8-88dc-c2dc434b2f8f | 3d69bc86-aa79-4f06-ab39-59aa41f82b54 | 2024-01-25 | Warnings | c9cb8c59-1b93-4fa8-88dc-c2dc434b2f8f 3d69bc86-aa79-4f06-ab39-59aa41f82b54 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.