Indications and uses
temporary relief of pain and itching helps relieve and soothes pain from sunburn, minor burns, cuts, scrapes, skin irritations and insect bites
temporary relief of pain and itching helps relieve and soothes pain from sunburn, minor burns, cuts, scrapes, skin irritations and insect bites
adults and children 2 years of age and older.apply to affected area not more than 3 to 4 times daily children under 2 years of age: do not use, ask a doctor.
Topical Analgesic
For external use only
Do not use in large quantities, particularly over raw surfaces or blistered areas.
If swallowed get medical help or contact a Poison Control Center right away.
Water, Propylene Glycol, Glycerin, Isopropyl Alcohol, Triethanolamine, Polysorbate 80, Carbomer, Aloe Barbadensis Leaf Juice Powder, Menthol, Disodium EDTA, Diazolidinyl Urea, Yellow 5, Blue 1.
| Class | Version | Type | Effective |
|---|---|---|---|
| LIDOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 070fbed5-7088-434a-a7ce-f2a64d8d40ac | Product name | 2 | 20260107 |
| bee66ce1-adb7-9d3b-67d9-582e4c54e80f | Product name | 5 | 20250819 |
| 860a93dc-4863-49cc-b284-6bbe8191bc48 | Product name | 4 | 20250214 |
| eaba870a-6a9d-442e-8643-87b3f558a451 | Product name | 1 | 20250117 |
| 6c13b22c-b3ba-4127-b768-0132dd5ab0d1 | Product name | 1 | 20230829 |
| 9b4cf230-fd05-41d5-98c6-5db9ecb27b86 | Product name | 1 | 20230117 |
| 7d755fa1-1087-4dcd-98f0-6d4bba479a57 | Product name | 3 | 20210602 |
| aed701d5-9c75-dfaf-7154-cde46179faea | Product name | 9 | 20200313 |
| fa8b5901-e681-426f-82fe-54f6d81ec698 | Product name | 4 | 20180619 |
| 332d03e4-aa24-4b11-841a-02bf41081920 | Product name | 1 | 20171221 |
| c08ab52f-2fc8-4409-9d9f-ed8edc0bd070 | Product name | 1 | 20171221 |
| 68ed98f8-24c2-44a0-944a-6d36e82ce25a | Product name | 1 | 20141222 |
| 1cd42bc2-a430-c72b-636d-991b235fbf80 | Product name | 1 | 20140508 |
| 49fa150c-f0de-cce7-3d9c-993ed81c5698 | Product name | 1 | 20140508 |
| 4d7ae718-ed00-bae8-2abe-9eaec1eef7ff | Product name | 1 | 20140508 |
| 9137811f-f279-8640-5aeb-99fa2145d64d | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55301-044-16 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-eb4b-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55301-044-16 | Exchange Select Burn ReliefPain Relieving | 227 g in 1 BOTTLE, PLASTIC | GEL | 227 | 1 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE | ACTIVE INGREDIENT | V13007Z41A | 1 | |
| LIDOCAINE | ACTIVE MOIETY | 98PI200987 | 1 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 1 | |
| DIAZOLIDINYL UREA | INACTIVE INGREDIENT | H5RIZ3MPW4 | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | 1 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 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 |
|---|---|
| 55301-044 | 55301-044-16 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LIDOCAINE HYDROCHLORIDE | V13007Z41A | ACTIB |
| WATER | 059QF0KO0R | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| DIAZOLIDINYL UREA | H5RIZ3MPW4 | IACT |
| MENTHOL | L7T10EIP3A | 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 |
|---|---|---|---|---|---|---|
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | GEL, METERED / TOPICAL | 525 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / ORAL | 432 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / SOFT TISSUE | 4 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | ENEMA / RECTAL | 60 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SYRUP / ORAL | 7.5 mg/5ml | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / OPHTHALMIC | 4 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / SUBCUTANEOUS | 1.4 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / RESPIRATORY (INHALATION) | 43 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | JELLY / TOPICAL | 20 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SHAMPOO / TOPICAL | 1 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY, METERED / NASAL | 4 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TAMPON / VAGINAL | 62.1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION / ORAL | 206 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET / SUBLINGUAL | 0.08 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SYSTEM / TOPICAL | 28 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, DELAYED RELEASE / ORAL | 1.7 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | GEL / TOPICAL | 12 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | LOTION / TOPICAL | 15 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| ISOPROPYL ALCOHOL | ISOPROPYL ALCOHOL | ND2M416302 | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL / TOPICAL | 19.2 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / NASAL | 5 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC | 0.05 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / ORAL | 2590 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 168.1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, COATED / ORAL | 16 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SOLUTION / INTRAVENOUS | 1170 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SHAMPOO, SUSPENSION / TOPICAL | 1 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 19 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INFILTRATION | 6 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / TOPICAL | 8 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | LOTION / TOPICAL | 22 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | LIQUID / TOPICAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / RECTAL | 90400 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRAVENOUS | 4680 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAVENOUS | 15 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | AEROSOL, FOAM / RECTAL | 2 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, COATED / ORAL | 0.21 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / VAGINAL | 750 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR | 5 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| MENTHOL | MENTHOL | L7T10EIP3A | SOLUTION / ORAL | 3 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CREAM / VAGINAL | 0.4 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION/ DROPS / AURICULAR (OTIC) | 13 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 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 |
|---|---|---|---|---|---|---|
| 4501e75d-7de2-4260-a145-a63cfeebfad3 | 3af9e017-e081-46f6-b6ba-64ab72bd0950 | 2012-11-15 | Warnings | 4501e75d-7de2-4260-a145-a63cfeebfad3 3af9e017-e081-46f6-b6ba-64ab72bd0950 |
Adverse event summaries are temporarily unavailable. Other product information remains available.