OTC - ACTIVE INGREDIENT SECTION
Active Ingredients Purpose
Menthol 2.0% Topical Anagesic
Active Ingredients Purpose
Menthol 2.0% Topical Anagesic
Purpose
Topical Analgesic
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with
Warnings
For external use only
When using this product
Stop use and ask a doctor if
condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.
Directions
Inactive ingredients carbomer, propylene glycol, methylparaben, isopropyl alcohol, triethanolamine, FD&C Blue #1, water
SSS Grou, LLC Miami, Fl 33183
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53113-108-08 | 2019-11-27 | C162847 | 48780-1 | 9855d018-df6d-cd31-e053-dbdaa90ab51a | 8ec2d086-67d8-4a2b-af0d-2d4bb6acce09 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53113-108-08 | Ice QuakeMuscle Rub | 228 g in 1 JAR | GEL | 228 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MENTHOL | ACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| MENTHOL | ACTIVE MOIETY | L7T10EIP3A | 1 | |
| CARBOMER 940 | INACTIVE INGREDIENT | 4Q93RCW27E | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 53113-108 | 53113-108-08 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MENTHOL | L7T10EIP3A | ACTIB |
| CARBOMER 940 | 4Q93RCW27E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| Water | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / OPHTHALMIC | 1 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LOTION / TOPICAL | 351 mg | ||
| CARBOMER 940 | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | GEL / TRANSDERMAL | 150 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM / SUBLINGUAL | 0.07 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED / ORAL | 25 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | LOTION / TOPICAL | 360 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED PELLETS / ORAL | NA | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | CREAM, AUGMENTED / TOPICAL | 20 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / RECTAL | 90400 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / TOPICAL | 0.01 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / RECTAL | 0.01 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | CREAM / TOPICAL | 1 %w/w | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | ELIXIR / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SUSPENSION / ORAL | 75 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / ORAL | 2590 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM / BUCCAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LIQUID / ORAL | 162 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / ORAL | 1 mg/1ml | ||
| CARBOMER 940 | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | GEL / OPHTHALMIC | 4 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / RESPIRATORY (INHALATION) | 25 %w/w | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | SOLUTION / NASAL | NA | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | SPONGE / TOPICAL | 11 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.01 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INFILTRATION | 80 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | DROPS / ORAL | 200 mg/1ml | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERINEURAL | 80 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IONTOPHORESIS | 0.1 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRAVENOUS | 95 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET / ORAL | 27.53 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | SPONGE / TOPICAL | 4 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TAMPON / VAGINAL | 62.1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, CHEWABLE / ORAL | 1.28 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CREAM / TOPICAL | 0.01 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | PASTE / DENTAL | 0.5 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION, AUGMENTED / TOPICAL | 2070 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL, METERED / TOPICAL | 1225 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CAPSULE / ORAL | 7 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / EPIDURAL | 30 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SOFT TISSUE | 0.15 %w/v | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | AEROSOL, METERED / RECTAL | ADJ PH | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAMUSCULAR | 45 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUPPOSITORY / VAGINAL | 252 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | SPRAY / NASAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, COATED / ORAL | 16 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, EXTENDED RELEASE / TRANSDERMAL | 58.13 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / INTRAVENOUS | 50.33 %w/v | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SUSPENSION / ORAL | 1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / NASAL | 5 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | OINTMENT / OPHTHALMIC | 0.05 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / OPHTHALMIC | 1.5 %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 |
|---|---|---|---|---|---|---|
| 3a135d16-cb5f-4ec6-815f-9993a96763cb | 8ec2d086-67d8-4a2b-af0d-2d4bb6acce09 | 2013-09-16 | Warnings | 3a135d16-cb5f-4ec6-815f-9993a96763cb 8ec2d086-67d8-4a2b-af0d-2d4bb6acce09 |
Adverse event summaries are temporarily unavailable. Other product information remains available.