OTC - ACTIVE INGREDIENT SECTION
Active Ingredients Purpose
Methyl Salicylate 8% Topical Analgesic
Menthol 2% Topical Analgesic
Active Ingredients Purpose
Methyl Salicylate 8% Topical Analgesic
Menthol 2% Topical Analgesic
Purpose
Topical Analgesic
Uses
For the temporary relief of minor aches and pains of muscles and joints due to
Warnings
For external use only
When using this product: Use only as directed
Stop use and ask a doctor if
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.
Directions
Inactive ingredients: mineral oil, propylene glycol, cetyl stearyl alcohol, purified water, ceteareth-6, stearyl alcohol, PEG-20 Cetyl/stearyl ether, methylparaben, propylparaben
SSS Group, LLC Miami, Fl 33183
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53113-688-05 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e1e3-cd31-e053-dbdaa90ab51a | 700b3dab-0b6c-44ea-8866-e9cffa81fc0e |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53113-688-05 | Ice QuakeWhite | 60 g in 1 TUBE | CREAM | 60 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| METHYL SALICYLATE | ACTIVE INGREDIENT | LAV5U5022Y | 1 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | 1 | |
| SALICYLIC ACID | ACTIVE MOIETY | O414PZ4LPZ | 1 | |
| CETEARETH-6 | INACTIVE INGREDIENT | 2RJS3559D3 | 1 | |
| CETOSTEARYL ALCOHOL | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| POLYOXYL 20 CETOSTEARYL ETHER | INACTIVE INGREDIENT | YRC528SWUY | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 53113-688 | 53113-688-05 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MENTHOL | L7T10EIP3A | ACTIB |
| METHYL SALICYLATE | LAV5U5022Y | ACTIB |
| MINERAL OIL | T5L8T28FGP | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| WATER | 059QF0KO0R | IACT |
| CETEARETH-6 | 2RJS3559D3 | IACT |
| STEARYL ALCOHOL | 2KR89I4H1Y | IACT |
| POLYOXYL 20 CETOSTEARYL ETHER | YRC528SWUY | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | 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 |
|---|---|---|---|---|---|---|
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / ORAL | 64 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / TOPICAL | 2772 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / AURICULAR (OTIC) | 10 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | ENEMA / RECTAL | 0.18 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | ELIXIR / ORAL | 9306 mg | ||
| POLYOXYL 20 CETOSTEARYL ETHER | POLYOXYL 20 CETOSTEARYL ETHER | YRC528SWUY | GEL / TOPICAL | 2 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SHAMPOO, SUSPENSION / TOPICAL | 0.15 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / PARENTERAL | 30 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| POLYOXYL 20 CETOSTEARYL ETHER | POLYOXYL 20 CETOSTEARYL ETHER | YRC528SWUY | SUSPENSION / ORAL | 20 mg | ||
| POLYOXYL 20 CETOSTEARYL ETHER | POLYOXYL 20 CETOSTEARYL ETHER | YRC528SWUY | CREAM / TOPICAL | 180 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM, AUGMENTED / TOPICAL | 8 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / EPIDURAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET / ORAL | 1.8 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SUBCUTANEOUS | 22 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| CETOSTEARYL ALCOHOL | CETOSTEARYL ALCOHOL | 2DMT128M1S | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | GEL / TOPICAL | 2.5 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | LIQUID / TOPICAL | 0.1 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED / ORAL | 25 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION/ DROPS / OPHTHALMIC | 0.05 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUPPOSITORY / VAGINAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / SUBCUTANEOUS | 1.4 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAMUSCULAR | 4000 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | OINTMENT / TOPICAL | 29 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / TOPICAL | 5.28 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION/ DROPS / OPHTHALMIC | 0.01 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CONCENTRATE / ORAL | 12 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE / ORAL | 120 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / VAGINAL | 402 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SPRAY / TOPICAL | 0.8 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / VAGINAL | 30 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SOLUTION / ORAL | 13 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | LOTION / TOPICAL | 1140 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / DENTAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / TOPICAL | 47.5 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, COATED / ORAL | 16 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL, METERED / TOPICAL | 1225 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / INTRAMUSCULAR | 0.13 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | FILM, SOLUBLE / BUCCAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | DROPS / OPHTHALMIC | 0.01 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SUSPENSION / ORAL | 75 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / SUBCUTANEOUS | 1.4 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / AURICULAR (OTIC) | 0.01 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / TOPICAL | 4886 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | POWDER / ORAL | 0.11 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUPPOSITORY / VAGINAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / OPHTHALMIC | 0.6 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / SUBCUTANEOUS | 2 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / OPHTHALMIC | 0.1 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / INTRAMUSCULAR | 0.02 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | DROPS / ORAL | NA | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | CAPSULE, EXTENDED RELEASE / ORAL | 72 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO, SUSPENSION / TOPICAL | 2 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | OINTMENT / OPHTHALMIC | 0.05 %w/w |
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 |
|---|---|---|---|---|---|---|
| 6720c67b-21f5-485d-90e1-c40bad7dd1f6 | 700b3dab-0b6c-44ea-8866-e9cffa81fc0e | 2013-09-20 | Warnings | 6720c67b-21f5-485d-90e1-c40bad7dd1f6 700b3dab-0b6c-44ea-8866-e9cffa81fc0e |
Adverse event summaries are temporarily unavailable. Other product information remains available.