Indications and uses
temporarily relieves pain and itching due to: minor skin irritations sunburn minor burns scrapes minor cuts insect bites
Leader Burn Relief Gel
- Manufacturer
- Cardinal Health
- Effective date
- 2024-10-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:51:32
Label at a glance#
ProductLeader Burn Relief
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure12 sections
Dosage and administration
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.
Label contents#
Full prescribing information#
Active ingredient
Lidocaine 1.0% (as Lidocaine HCl)
Purpose
External analgesic
Uses
temporarily relieves pain and itching due to:
- minor skin irritations
- sunburn
- minor burns
- scrapes
- minor cuts
- insect bites
Warnings
For external use only
Do not use
in large quantities, particularly over raw surfaces or blistered areas
When using this product
• Avoid contact with eyes. If contact occurs, rinse with water to remove.
Stop use and ask a doctor if
- condition gets worse
- symptoms last more than 7 days
- symptoms clear up and occur again in a few days
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- 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.
Other information
may stain some fabrics
Inactive ingredients
aloe barbadensis leaf juice, triethanolamine, isoceteth-20, carbomer, tetrasodium EDTA, methylchloroisothiazolinone, methylisothiazolinone, water, benzophenone-4, blue 1.
Label
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70000-0537 | LEADER BURN RELIEF (LIDOCAINE HYDROCHLORIDE) GEL [CARDINAL HEALTH] | 3 | Legacy NDC | 20241024_98e61979-6ce4-5033-e053-2995a90a2905.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0537-1 | GM - Gram | 70000-0537 | 3b64baf8-107b-4aef-8dde-d364e8404d2e | 1 | 2020-07-13 |
Products#
Every source-derived product name is available through these pages.
- Leader Burn Relief
- Lidocaine Hydrochloride
- WATER
- FD&C BLUE NO. 1
- TROLAMINE
- ISOCETETH-20
- EDETATE SODIUM
- EDETIC ACID
- ALOE VERA LEAF
- SULISOBENZONE
- CARBOMER INTERPOLYMER TYPE A (55000 CPS)
- METHYLISOTHIAZOLINONE
- METHYLCHLOROISOTHIAZOLINONE
- LIDOCAINE
- LIDOCAINE HYDROCHLORIDE ANHYDROUS
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70000-0537 | 70000-0537-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| TROLAMINE | 9O3K93S3TK | IACT |
| ISOCETETH-20 | O020065R7Z | IACT |
| EDETATE SODIUM | MP1J8420LU | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| SULISOBENZONE | 1W6L629B4K | IACT |
| CARBOMER INTERPOLYMER TYPE A (55000 CPS) | 59TL3WG5CO | IACT |
| METHYLISOTHIAZOLINONE | 229D0E1QFA | IACT |
| METHYLCHLOROISOTHIAZOLINONE | DEL7T5QRPN | IACT |
| LIDOCAINE HYDROCHLORIDE | V13007Z41A | ACTIR |
Source Document#
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| 251885c0-9984-5dbe-e063-6394a90ac3cb | 98e61979-6ce4-5033-e053-2995a90a2905 | 2024-10-22 | Warnings | 251885c0-9984-5dbe-e063-6394a90ac3cb 98e61979-6ce4-5033-e053-2995a90a2905 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.