OTC - ACTIVE INGREDIENT SECTION
Active Ingredient : Menthol 2.0 %
Active Ingredient : Menthol 2.0 %
Purpose : External Analgesic
Warnings : For external use only
Keep Out of Reach of Children : In case of accidental ingestion , get medical help or contact a Position Control center right away.
Inactive Ingredients : water , isopropyl alcohol , aloe barbadensis leaf juice , hydroxyethylcellulose , chamomilla recutita (matricaria) flower , eucalyptus globulus leaf oil , polysorbate 80 , fragrance , methylparaben , dmdm hydantoin
Uses : Temporarily relieves minor aches and pains of muscles and joints due to * arthritis * simple backache * strains * sprains
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66391-0046-0 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-ccd7-8e05-e053-dbdaa90a074a | 70a304d9-755b-40a2-a48e-491c8355410c |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66391-0046-0 | Miracle of Aloe Rub Roll On | 90 mL in 1 BOTTLE, WITH APPLICATOR | LIQUID | 90 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 66391-0046 | MIRACLE OF ALOE RUB ROLL ON (MENTHOL) LIQUID [WINNING SOLUTIONS] | 1 | Legacy NDC, 1 package rows | 20110818_70a304d9-755b-40a2-a48e-491c8355410c.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Menthol | ACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| Menthol | ACTIVE MOIETY | L7T10EIP3A | 1 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 1 | |
| CHAMOMILE | INACTIVE INGREDIENT | FGL3685T2X | 1 | |
| CORYMBIA CITRIODORA LEAF OIL | INACTIVE INGREDIENT | M63U6N96EB | 1 | |
| dmdm hydantoin | INACTIVE INGREDIENT | BYR0546TOW | 1 | |
| HYDROXYETHYL CELLULOSE (140 CPS AT 5%) | INACTIVE INGREDIENT | 8136Y38GY5 | 1 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | 1 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| polysorbate 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 66391-0046 | 66391-0046-0 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Menthol | L7T10EIP3A | ACTIB |
| Water | 059QF0KO0R | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| HYDROXYETHYL CELLULOSE (140 CPS AT 5%) | 8136Y38GY5 | IACT |
| CHAMOMILE | FGL3685T2X | IACT |
| CORYMBIA CITRIODORA LEAF OIL | M63U6N96EB | IACT |
| polysorbate 80 | 6OZP39ZG8H | IACT |
| methylparaben | A2I8C7HI9T | IACT |
| dmdm hydantoin | BYR0546TOW | 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 |
|---|---|---|---|---|---|---|
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, COATED / ORAL | 0.04 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERINEURAL | 80 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | LIQUID / INTRAVENOUS | 720 mg | ||
| HYDROXYETHYL CELLULOSE (140 CPS AT 5%) | HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) | 8136Y38GY5 | SUSPENSION / ORAL | 1200 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | EMULSION / TOPICAL | 0.2 %w/w | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | GEL / TOPICAL | 75 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRAVENOUS | 4680 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS | 4739 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / AURICULAR (OTIC) | NA | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / VAGINAL | 0.1 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, SUSPENSION / INTRAMUSCULAR | 1 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 4 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | SPRAY, METERED / NASAL | 0.1 mg/1ml | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / AURICULAR (OTIC) | 0.2 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RESPIRATORY (INHALATION) | 0.03 %w/w | ||
| HYDROXYETHYL CELLULOSE (140 CPS AT 5%) | HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) | 8136Y38GY5 | CAPSULE / ORAL | 20 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SUPPOSITORY / VAGINAL | NA | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / EPIDURAL | 1 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRA-ARTICULAR | 4 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 34 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / OPHTHALMIC | 8 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION, CONCENTRATE / ORAL | 1 mg/1ml | ||
| dmdm hydantoin | DMDM HYDANTOIN | BYR0546TOW | LOTION / TOPICAL | 3 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / RECTAL | 315 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / TOPICAL | 0.24 %w/v | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 53 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 3.6 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | CONCENTRATE / ORAL | 1 mg/1ml | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.16 %w/v | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SHAMPOO / TOPICAL | 0.15 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / TOPICAL | 0.16 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / INTRAVENOUS | 900 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | TABLET, EXTENDED RELEASE / ORAL | 0.17 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | POWDER / ORAL | 66 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | CONCENTRATE / INTRAVENOUS | 4680 mg | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | SPONGE / TOPICAL | 4 %w/w | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, EXTENDED RELEASE / ORAL | 10 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | GEL / TOPICAL | 24 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 900 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRASYNOVIAL | 0.2 %w/v | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | EMULSION / OPHTHALMIC | 26 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION/ DROPS / OPHTHALMIC | 1 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / OPHTHALMIC | 0.05 %w/w | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION/ DROPS / AURICULAR (OTIC) | 13 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SHAMPOO, SUSPENSION / TOPICAL | 0.15 %w/w | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION/ DROPS / ORAL | 23 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUPPOSITORY / RECTAL | 72.15 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / SOFT TISSUE | 4 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / RECTAL | 1808 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, DELAYED RELEASE / ORAL | 23 mg | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | SWAB / TOPICAL | 43.9 %w/w | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR | 5 mg | ||
| HYDROXYETHYL CELLULOSE (140 CPS AT 5%) | HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) | 8136Y38GY5 | FILM, SOLUBLE / BUCCAL | 161 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | TABLET / ORAL | 1.8 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERIDURAL | 1 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET / ORAL | 233 mg | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | CREAM / VAGINAL | 0.4 %w/w | ||
| polysorbate 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, DELAYED RELEASE / ORAL | 4 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 |
|---|---|---|---|---|---|---|
| 0d2db50d-5660-4d9d-af2a-f2ec0a2cc900 | 70a304d9-755b-40a2-a48e-491c8355410c | 2011-04-04 | Warnings | 0d2db50d-5660-4d9d-af2a-f2ec0a2cc900 70a304d9-755b-40a2-a48e-491c8355410c |
Adverse event summaries are temporarily unavailable. Other product information remains available.