OTC - ACTIVE INGREDIENT SECTION
Active Ingredients: Menthol
Active Ingredients: Menthol
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.
Use: For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains and/or sprains.
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 |
|---|---|---|---|
| 1043283 | ColdSpot POINT RELIEF 10 % Topical Spray | PSN | 6 |
| 667889 | menthol 10 % Topical Spray | PSN | 6 |
| 1043283 | menthol 100 MG/ML Topical Spray [Cold Spot] | SBD | 6 |
| 667889 | menthol 100 MG/ML Topical Spray | SCD | 6 |
| 1043283 | Cold Spot 0.1 ML/ML Topical Spray | SY | 6 |
| 1043283 | Cold Spot Point Relief 10 % Topical Spray | SY | 6 |
| 667889 | menthol 10 % Topical Spray | SY | 6 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65121-003-04 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-d970-8e05-e053-dbdaa90a074a | Cold Spot Point Relief Pain relieving Spray - 4 oz. Spray |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65121-003-04 | Cold SpotPoint Relief | 120 mL in 1 BOTTLE, SPRAY | AEROSOL, SPRAY | 120 | 6 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Menthol | ACTIVE INGREDIENT | L7T10EIP3A | 6 | |
| Menthol | ACTIVE MOIETY | L7T10EIP3A | 6 | |
| alcohol | INACTIVE INGREDIENT | 3K9958V90M | 6 | |
| Arnica cordifolia flower | INACTIVE INGREDIENT | JCG1OSZ7A8 | 6 | |
| Chondroitin sulfate (bovine) | INACTIVE INGREDIENT | 6IC1M3OG5Z | 6 | |
| Citric Acid | INACTIVE INGREDIENT | 2968PHW8QP | 6 | |
| Dimethyl Sulfone | INACTIVE INGREDIENT | 9H4PO4Z4FT | 6 | |
| Eucalyptus Globulus leaf | INACTIVE INGREDIENT | S546YLW6E6 | 6 | |
| Glucosamine sulfate | INACTIVE INGREDIENT | 1FW7WLR731 | 6 | |
| ILEX PARAGUARIENSIS LEAF | INACTIVE INGREDIENT | 1Q953B4O4F | 6 | |
| Isopropyl Alcohol | INACTIVE INGREDIENT | ND2M416302 | 6 | |
| Peppermint Oil | INACTIVE INGREDIENT | AV092KU4JH | 6 | |
| polysorbate 20 | INACTIVE INGREDIENT | 7T1F30V5YH | 6 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 6 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 65121-003 | 65121-003-04 |
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 |
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 |
|---|---|---|---|---|---|---|
| alcohol | ALCOHOL | 3K9958V90M | SOLUTION / RESPIRATORY (INHALATION) | 0.08 %w/v | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | DROPS / ORAL | NA | ||
| polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | SPRAY, METERED / NASAL | 40 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / PERIDURAL | NA | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION, EXTENDED RELEASE / ORAL | 140.8 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | CONCENTRATE / ORAL | 198 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | SWAB / TOPICAL | 2250 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / RESPIRATORY (INHALATION) | 8 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION/ DROPS / AURICULAR (OTIC) | 0.04 %w/w | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | NA | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRAMUSCULAR | 28 mg | ||
| polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | CREAM / TOPICAL | 108 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | SPRAY / SUBLINGUAL | 397 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | SOLUTION / NASAL | 10 mg/1ml | ||
| polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | CLOTH / TOPICAL | NA | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SHAMPOO, SUSPENSION / TOPICAL | 0.25 %w/v | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / ORAL | 114 mg | ||
| polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | CAPSULE / ORAL | 563 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | ELIXIR / ORAL | 13675 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | EMULSION / TOPICAL | 0.11 %w/w | ||
| alcohol | ALCOHOL | 3K9958V90M | MOUTHWASH / BUCCAL | 200 mg/1ml | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / INTRAVENOUS | 396 mg | ||
| Peppermint Oil | PEPPERMINT OIL | AV092KU4JH | SOLUTION / ORAL | 53 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / SUBCUTANEOUS | 26 mg | ||
| Peppermint Oil | PEPPERMINT OIL | AV092KU4JH | SYRUP / ORAL | 120 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / RESPIRATORY (INHALATION) | 0.03 %w/v | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SPRAY / NASAL | 9 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / SUBCUTANEOUS | 28 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | GEL / DENTAL | 1.8 %w/w | ||
| Peppermint Oil | PEPPERMINT OIL | AV092KU4JH | FILM / BUCCAL | 12 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | INJECTION / INTRAVASCULAR | 100 %v/v | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET / ORAL | 914 mg | ||
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | ND2M416302 | GEL / TOPICAL | 75 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | GEL, METERED / TRANSDERMAL | 3675 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYRUP / ORAL | 722 mg/5ml | ||
| Peppermint Oil | PEPPERMINT OIL | AV092KU4JH | TABLET / ORAL | 28 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | SOLUTION / DENTAL | 12.8 %w/w | ||
| alcohol | ALCOHOL | 3K9958V90M | AEROSOL, METERED / NASAL | 70 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / ORAL | 269 mg | ||
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | ND2M416302 | OIL / AURICULAR (OTIC) | 6 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET / SUBLINGUAL | 24 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOAP / TOPICAL | 0.5 %w/w | ||
| alcohol | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / TOPICAL | 561 mg | ||
| polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | SOLUTION / TOPICAL | 15 %w/w | ||
| Peppermint Oil | PEPPERMINT OIL | AV092KU4JH | CONCENTRATE / ORAL | 0.05 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / INTRAMUSCULAR | 26 mg | ||
| polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 60 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | AEROSOL, FOAM / TOPICAL | 1 mg | ||
| Peppermint Oil | PEPPERMINT OIL | AV092KU4JH | GUM, CHEWING / ORAL | 526 mg | ||
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | ND2M416302 | OIL / TOPICAL | 72 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION, CONCENTRATE / INTRAVENOUS | NA | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAMUSCULAR | 0.05 %w/v | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, CHEWABLE / ORAL | 7 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | SPRAY / NASAL | 20 mg | ||
| polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | AEROSOL, FOAM / VAGINAL | 3 %w/w | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, EFFERVESCENT / ORAL | 460 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / INTRAVENOUS | 4000 mg | ||
| Citric Acid | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / ORAL | 446 mg | ||
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | ND2M416302 | SOLUTION / TOPICAL | 40 %w/v |
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 |
|---|---|---|---|---|---|---|
| 57ba08ba-4077-403b-b2b8-d17495d8d27f | 2a86e0fc-a65a-4951-8b38-03636b83fff8 | 2010-08-28 | Warnings | 57ba08ba-4077-403b-b2b8-d17495d8d27f 2a86e0fc-a65a-4951-8b38-03636b83fff8 |
Adverse event summaries are temporarily unavailable. Other product information remains available.