OTC - ACTIVE INGREDIENT SECTION
Lidocaine 0.5%
Lidocaine 0.5%
External Analgesic.
For the temporary relief of pain and itching due to sunburn, minor burns, insect bites, minor cuts, scrapes, and minor skin irritations.
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 avoid contact with eyes. Rinse with water to remove. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F.
Stop use and ask a doctor if the condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.
Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.
Shake well before use. Adults and children 2 years and older: apply to the affected area, not more than 3 to 4 times a day. Children under 2 years of age: ask a doctor. To apply to face, spray in palm of hand and gently apply.
Water, Alcohol Denat., Propylene Glycol, Glycerin, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Disodium Cocoamphodipipropionate, Carbomer, Disodium EDTA, Triethanolamine, Diazolidinyl Urea, Propylparaben, methylparaben, Simethicone.
| Class | Version | Type | Effective |
|---|---|---|---|
| LIDOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70000-0624-1 | Leader Burn Relief | 128 g in 1 BOTTLE, PLASTIC | SPRAY | 128 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70000-0624 | LEADER BURN RELIEF (LIDOCAINE) SPRAY [CARDINAL HEALTH] | 2 | Current NDC, 1 package rows | 20240207_f4e8e3b7-fd84-bdbc-e053-2a95a90aeab2.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0624-1 | GM - Gram | 70000-0624 | 1b680e2c-b72b-44e1-95c5-64a7b3bda220 | 1 | 2024-02-14 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 70000-0624 | 70000-0624-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| LIDOCAINE | 98PI200987 | ACTIB |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| CARBOMER 940 | 4Q93RCW27E | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| DIAZOLIDINYL UREA | H5RIZ3MPW4 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| DISODIUM COCOAMPHODIPROPIONATE | 6K8PRP397M | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
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 |
|---|---|---|---|---|---|---|
| Leader Burn Relief | LIDOCAINE | Cardinal Health | f4e8e3b7-fd84-bdbc-e053-2a95a90aeab2 | 2024-02-06 | Warnings | 70000-0624-1 70000-0624 70000062401 10ba9afc-73fc-c8a3-e063-6294a90a8adc f4e8e3b7-fd84-bdbc-e053-2a95a90aeab2 |
Adverse event summaries are temporarily unavailable. Other product information remains available.