OTC - ACTIVE INGREDIENT SECTION
Active Ingredients: Menthol, methyl salicylate.
Active Ingredients: Menthol, methyl salicylate.
Inactive Ingredients: deionized water, arnica, chondroitin sulfate, citirc acid, euclayptus oil, glucosamine sulfate, ilex paraguariesis leaf, isopropyl alcohol, peppermint oil, dimethyl sulfone, polysorbate-20, SD alcohol 40B.
Keep out of reach of children. If swallowed consult physician
Warnings Section: For external use only, avoid contact with eyes, do not apply to open wounds or damaged skin, if symptoms persist for more than seven days discontinue use and consult physician, keep out of reach of children and if swallowed consult physician, do not bandage tightly.
pain relieving gel.
For
temporary relief of minor aches and pains of the muscles and joints
associated with simple backache, arthritis, bruises, strains and/or
sprains.
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1235996 | ColdSpot POINT RELIEF 12 % / 4 % Topical Gel | PSN | 5 |
| 1045442 | menthol 12 % / methyl salicylate 4 % Topical Gel | PSN | 5 |
| 1235996 | menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG Topical Gel [Cold Spot with Methyl Salicylate] | SBD | 5 |
| 1045442 | menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG Topical Gel | SCD | 5 |
| 1235996 | Cold Spot Point Relief with Methyl Salicylate (menthol 12 % / methyl salicylate 4 % ) Topical Gel | SY | 5 |
| 1235996 | Cold Spot with Methyl Salicylate (menthol 0.12 MG/MG / methyl salicylate 0.04 MG/MG) Topical Gel | SY | 5 |
| 1045442 | menthol 12 % / methyl salicylate 4 % Topical Gel | SY | 5 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65121-001-00 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-c1d0-8e05-e053-dbdaa90a074a | Cold Spot Point Relief Pain relieving Gel - 5 G |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65121-001-00 | Cold SpotPoint Relief | 5 g in 1 BOTTLE, DISPENSING | GEL | 5 | 5 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Menthol | ACTIVE INGREDIENT | L7T10EIP3A | 5 | |
| METHYL SALICYLATE | ACTIVE INGREDIENT | LAV5U5022Y | 5 | |
| Menthol | ACTIVE MOIETY | L7T10EIP3A | 5 | |
| SALICYLIC ACID | ACTIVE MOIETY | O414PZ4LPZ | 5 | |
| alcohol | INACTIVE INGREDIENT | 3K9958V90M | 5 | |
| ARNICA CORDIFOLIA FLOWER | INACTIVE INGREDIENT | JCG1OSZ7A8 | 5 | |
| CHONDROITIN SULFATE (BOVINE) | INACTIVE INGREDIENT | 6IC1M3OG5Z | 5 | |
| Citric Acid | INACTIVE INGREDIENT | 2968PHW8QP | 5 | |
| Dimethyl Sulfone | INACTIVE INGREDIENT | 9H4PO4Z4FT | 5 | |
| EUCALYPTUS GLOBULUS LEAF | INACTIVE INGREDIENT | S546YLW6E6 | 5 | |
| Glucosamine sulfate | INACTIVE INGREDIENT | 1FW7WLR731 | 5 | |
| Ilex Paraguariensis Leaf | INACTIVE INGREDIENT | 1Q953B4O4F | 5 | |
| Isopropyl Alcohol | INACTIVE INGREDIENT | ND2M416302 | 5 | |
| Peppermint Oil | INACTIVE INGREDIENT | AV092KU4JH | 5 | |
| polysorbate 20 | INACTIVE INGREDIENT | 7T1F30V5YH | 5 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 5 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 65121-001 | 65121-001-00 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Menthol | L7T10EIP3A | ACTIB |
| water | 059QF0KO0R | IACT |
| ARNICA CORDIFOLIA FLOWER | JCG1OSZ7A8 | IACT |
| CHONDROITIN SULFATE (BOVINE) | 6IC1M3OG5Z | IACT |
| Citric Acid | 2968PHW8QP | IACT |
| EUCALYPTUS GLOBULUS LEAF | S546YLW6E6 | IACT |
| Glucosamine sulfate | 1FW7WLR731 | IACT |
| Ilex Paraguariensis Leaf | 1Q953B4O4F | IACT |
| Isopropyl Alcohol | ND2M416302 | IACT |
| Peppermint Oil | AV092KU4JH | IACT |
| Dimethyl Sulfone | 9H4PO4Z4FT | IACT |
| polysorbate 20 | 7T1F30V5YH | IACT |
| alcohol | 3K9958V90M | IACT |
| METHYL SALICYLATE | LAV5U5022Y | ACTIB |
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 |
|---|---|---|---|---|---|---|
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | GRANULE, FOR SUSPENSION / ORAL | 113 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, FILM COATED / ORAL | 42 mg | ||
| Peppermint Oil | PEPPERMINT OIL | AV092KU4JH | TABLET / SUBLINGUAL | 0.15 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / TOPICAL | 17 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAMUSCULAR | 0.05 %w/v | ||
| alcohol | ALCOHOL | 3K9958V90M | GEL / RECTAL | 898 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / IONTOPHORESIS | 0.02 %w/v | ||
| polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | LOTION / TOPICAL | 2000 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | SWAB / TOPICAL | 2250 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | SOLUTION / ORAL | 6624 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | CONCENTRATE / BUCCAL | 679 mg/1ml | ||
| Peppermint Oil | PEPPERMINT OIL | AV092KU4JH | TABLET / ORAL | 28 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | GEL / TOPICAL | 1 mg | ||
| polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | SOAP / TOPICAL | 0.02 %w/w | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, ORALLY DISINTEGRATING / ORAL | 83 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | DOUCHE / VAGINAL | 0.07 %w/w | ||
| polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION / INTRAVENOUS | 30 mg | ||
| Peppermint Oil | PEPPERMINT OIL | AV092KU4JH | GUM, CHEWING / BUCCAL | 526 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | CONCENTRATE / ORAL | 198 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | SOLUTION / RESPIRATORY (INHALATION) | 0.08 %w/v | ||
| alcohol | ALCOHOL | 3K9958V90M | JELLY / VAGINAL | NA | ||
| alcohol | ALCOHOL | 3K9958V90M | PASTE / DENTAL | 1.8 %w/w | ||
| polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION, SOLUTION / SUBCUTANEOUS | NA | ||
| polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | EMULSION / TOPICAL | 2 %w/w | ||
| alcohol | ALCOHOL | 3K9958V90M | MOUTHWASH / BUCCAL | 200 mg/1ml | ||
| alcohol | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAVENOUS | 6405 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION, SOLUTION / INTRAVENOUS | 30 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | OINTMENT / TOPICAL | 1 mg | ||
| Peppermint Oil | PEPPERMINT OIL | AV092KU4JH | SOLUTION / DENTAL | 0.04 %v/v | ||
| polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | SUSPENSION / OPHTHALMIC | 0.05 %w/v | ||
| Peppermint Oil | PEPPERMINT OIL | AV092KU4JH | FILM / BUCCAL | 12 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER / ORAL | 840 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | AEROSOL / NASAL | 20 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | POWDER, FOR SOLUTION / TOPICAL | 40 %w/w | ||
| Peppermint Oil | PEPPERMINT OIL | AV092KU4JH | OINTMENT / TOPICAL | 0.2 %w/w | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | FILM / SUBLINGUAL | 10 mg | ||
| Peppermint Oil | PEPPERMINT OIL | AV092KU4JH | SOLUTION / ORAL | 53 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / RESPIRATORY (INHALATION) | 0.13 %w/w | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | DROPS / ORAL | NA | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / ORAL | 114 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYSTEM / TOPICAL | 0.2 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | INJECTION / INTRAMUSCULAR | 1491 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRATHECAL | ADJ PH | ||
| alcohol | ALCOHOL | 3K9958V90M | LIQUID / RESPIRATORY (INHALATION) | 5 %w/w | ||
| alcohol | ALCOHOL | 3K9958V90M | SOLUTION / DENTAL | 12.8 %w/w | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / SUBCUTANEOUS | 26 mg | ||
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | ND2M416302 | SOLUTION / TOPICAL | 40 %w/v | ||
| alcohol | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVENOUS | 99 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | AEROSOL, FOAM / TOPICAL | 4504 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | LIQUID / INTRAMUSCULAR | 400 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SOLUTION / ORAL | 315 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SWAB / TOPICAL | 0.05 %w/w | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION/ DROPS / ORAL | 19 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRAMUSCULAR | 28 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CAPSULE, EXTENDED RELEASE / ORAL | 101 mg | ||
| polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | TABLET, FILM COATED / ORAL | 0.35 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SHAMPOO / TOPICAL | 17 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / EPIDURAL | 0.02 %w/v | ||
| Peppermint Oil | PEPPERMINT OIL | AV092KU4JH | GUM, CHEWING / ORAL | 526 mg |
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 |
|---|---|---|---|---|---|---|
| d9351ee3-9e8e-4325-8868-c7ccb17d3c3a | 1b2efd8c-1878-43d6-b7e5-d431852e8a10 | 2010-08-28 | Warnings | d9351ee3-9e8e-4325-8868-c7ccb17d3c3a 1b2efd8c-1878-43d6-b7e5-d431852e8a10 |
Adverse event summaries are temporarily unavailable. Other product information remains available.