OTC - ACTIVE INGREDIENT SECTION
Lidocaine 0.50%
Lidocaine 0.50%
Uses
Temporarily relieves pain and itching due to: sunburn, minor burns, minor cuts, scrapes, insect bites, minor skin irritations.
Warnings
For external use only. Flammable: do not use while smoking or near heat or flame. Do not use in large quantities, particularly over raw surfaces or blistered areas. When using this product: keep out of eyes, use only as directed, do not puncture or incinerate. Contents under pressure. Do no store at temperatures above 120 deg F. Stop use and ask doctor if: condition gets worse, symptoms last more than 7 days, or symptoms clear up and occur again in a few days.
Directions
Shake well. 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: ask a doctor. To apply to face, spray into palm of hand and gently apply.
Inactive ingredients
Aloe Barbadensis Leaf Juice, SD Alcohol 40, Propylene Glycol, Glycerin, Simethicone, Tocopheryl Acetate, Triethanolamine, Carbomer, Diazolidinyl Urea, Methylparaben, Propylparaben, Disodium Cocoamphodipropionate, Disodium EDTA.
Purpose
External analgesic.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Burn Relief Spray with Lidocaine.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 37205-613-11 | 2025-04-22 | C162847 | 48780-1 | 9d75b9d0-b140-f424-e053-dadaa90a57ce | Drug Facts |
| 37205-613-11 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b140-f424-e053-dadaa90a57ce | Drug Facts |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 37205-613-11 | GM - Gram | 37205-613 | 802f2481-b60a-42c6-b198-a7e66d515753 | 1 | 2014-04-03 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Lidocaine | ACTIVE INGREDIENT | 98PI200987 | 1 | |
| Lidocaine | ACTIVE MOIETY | 98PI200987 | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE, D- | INACTIVE INGREDIENT | A7E6112E4N | 1 | |
| Alcohol | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| Aloe | INACTIVE INGREDIENT | V5VD430YW9 | 1 | |
| CARBOMER HOMOPOLYMER TYPE C | INACTIVE INGREDIENT | 4Q93RCW27E | 1 | |
| DIAZOLIDINYL UREA | INACTIVE INGREDIENT | H5RIZ3MPW4 | 1 | |
| Edetate Disodium | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| Propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 37205-613 | 37205-613-11 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Lidocaine | 98PI200987 | ACTIB |
| Aloe | V5VD430YW9 | IACT |
| Alcohol | 3K9958V90M | IACT |
| Propylene Glycol | 6DC9Q167V3 | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| .ALPHA.-TOCOPHEROL ACETATE, D- | A7E6112E4N | IACT |
| CARBOMER HOMOPOLYMER TYPE C | 4Q93RCW27E | IACT |
| DIAZOLIDINYL UREA | H5RIZ3MPW4 | IACT |
| Methylparaben | A2I8C7HI9T | IACT |
| Propylparaben | Z8IX2SC1OH | IACT |
| Edetate Disodium | 7FLD91C86K | 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 | FILM, SOLUBLE / BUCCAL | 5 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAMUSCULAR | 450 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TRANSDERMAL | 500 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / ORAL | 27120 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | SUSPENSION / ORAL | 681 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / INTRAVENOUS | 5 %w/v | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | LOTION / TOPICAL | 351 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / PARENTERAL | 18 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / INTRAMUSCULAR | 400 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / ORAL | 432 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / NASAL | 10 mg/1ml | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE, EXTENDED RELEASE / ORAL | 0.22 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION/ DROPS / OPHTHALMIC | 0.01 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RESPIRATORY (INHALATION) | 0.03 %w/w | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SYSTEM / TOPICAL | 126 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | TABLET, CHEWABLE / ORAL | 1.28 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SPRAY / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| DIAZOLIDINYL UREA | DIAZOLIDINYL UREA | H5RIZ3MPW4 | OINTMENT / TOPICAL | 0.1 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / AURICULAR (OTIC) | 0.1 %w/v | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SOLUTION / INTRAVENOUS | 5 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED / ORAL | 25 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / TOPICAL | 4886 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / AURICULAR (OTIC) | NA | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | TABLET, COATED / ORAL | 0.8 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION, EXTENDED RELEASE / ORAL | 4 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 0.4 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | EMULSION / OPHTHALMIC | 0.3 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SYRUP / ORAL | 40 mg | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / TOPICAL | 0.2 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY, METERED / NASAL | 240 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / AURICULAR (OTIC) | 0.01 %w/v | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / RECTAL | 271 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / TRANSDERMAL | 49.37 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 35.75 %w/w | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / INTRAMUSCULAR | 4 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | ENEMA / RECTAL | 60 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / OPHTHALMIC | 0.05 %w/w | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRADERMAL | 1 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / PARENTERAL | 30 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVESICAL | 7892 mg | ||
| Methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / SUBCUTANEOUS | 22 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | PASTE / DENTAL | 1.8 %w/w | ||
| Propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / SUBCUTANEOUS | 2 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 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 |
|---|---|---|---|---|---|---|
| d9f29072-8cb1-4b6e-8d36-36f2d2d5cd75 | fa64a861-2c70-4ba5-b302-a48a0de8c1da | 2025-04-16 | Warnings | fa64a861-2c70-4ba5-b302-a48a0de8c1da |
Adverse event summaries are temporarily unavailable. Other product information remains available.