OTC - ACTIVE INGREDIENT SECTION
Lidocaine USP 0.50%
Lidocaine USP 0.50%
Purpose ..................External analgesic
Uses Temporary Relief of pain and itching due to: sunburn, minor burns, minor cuts scrapes, insect bites, minor skin irritations
Warnings
For external use only
DO not use in large quantities, particularly over raw surfaces or blistered area
When using this product, avoid contact with eyes, use only as directed, do not puncture or incinerate, content under pressure, do not store at temperature above 120 F.
Stop use and ask a doctor if, condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.
Keep out of reach of children, In case of accidental ingestion seek professional assistance or contact a Poison Control Center immediately.
Direction, Shake well, adults and children 2 years of age and older: Apply to affected area no more than 3 to 4 times daily. Wash hands with soap. Children under 2 years of age: consult a doctor. to apply to face, spray into palm of hand and gently apply.
Inactive ingredients
Aloe Barbadensis Leaf Extract
Carbomer
Diazolidinyl Urea
Disodium Cocoamphodipropionate
Disodium EDTA
Glycerin
Methylparaben
Propylene Glycol
Propylparaben
SD Alcohol 40
Simethicone
Tocopheryl Acetate
Triethanolamine
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21130-144-01 | 2025-12-12 | C162847 | 48780-1 | d6a99b39-bd0f-a426-e053-dadaa90af4c2 | Signature Care Burn Relief Continuous Spray Lidocaine 0.5% |
| 21130-144-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-bd0f-a426-e053-dadaa90af4c2 | Signature Care Burn Relief Continuous Spray Lidocaine 0.5% |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 21130-144 | 21130-144-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| EDETATE DISODIUM ANHYDROUS | 8NLQ36F6MM | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| CARBOMER 940 | 4Q93RCW27E | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| LIDOCAINE | 98PI200987 | ACTIB |
| DISODIUM COCOAMPHODIPROPIONATE | 6K8PRP397M | IACT |
| DIAZOLIDINYL UREA | H5RIZ3MPW4 | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
| .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| TROLAMINE | 9O3K93S3TK | 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 |
|---|---|---|---|---|---|---|
| 45c8ee30-4b74-9540-e063-6294a90af8a1 | a2cd84c6-b769-022f-e053-2995a90af939 | 2025-12-12 | Warnings | a2cd84c6-b769-022f-e053-2995a90af939 |
Adverse event summaries are temporarily unavailable. Other product information remains available.