Indications and uses
For the temporary relief of pain, irritation and itching associated with radiation dermatitis, mild burns, and sunburn.
For the temporary relief of pain, irritation and itching associated with radiation dermatitis, mild burns, and sunburn.
Adults and children 13 years old and older. Wash and dry affected area. Unless directed do not apply more than three to four times a day. Do not use 1 hour prior to radiation treatment. Wash hands immediately afterwards to avoid contact with eyes. Typical application is a quarter size amount over affected area.
LIDOCAINE HCL 4%
TOPICAL ANALGESIC/ANESTHETIC
Keep out of reach of children.
Water, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Aloe Barbadensis Leaf Juice, Isopentyldiol, Polyglyceryl-2 Stearate, Cetearyl Methicone, Dimethicone, Hydrogenated Polyisobutene, Butylene Glycol, Stearyl Phosphate, Calendula Officinalis Flower Extract, Sodium Hyaluronate, Tetrahexyldecyl Ascorbate, Xanthan Gum, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Disodium EDTA, Sodium Hydroxide, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Sodium Benzoate, Fragrance
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 71320-200-06 | 2023-03-30 | C162847 | 48780-1 | 9d75b9d0-37db-f424-e053-dadaa90a57ce | MIADERM-L - RADIATION RELIEF |
| 71320-200-06 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-37db-f424-e053-dadaa90a57ce | MIADERM-L - RADIATION RELIEF |
| 71320-200-06 | 2021-01-20 | C162847 | 48780-1 | 9d75b9d0-37db-f424-e053-dadaa90a57ce | MIADERM-L - RADIATION RELIEF |
| 71320-200-06 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-37db-f424-e053-dadaa90a57ce | MIADERM-L - RADIATION RELIEF |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 71320-200 | 71320-200-06 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| f820ca4e-b093-bd2e-e053-6394a90a6ff1 | 9ad8885f-e450-43ad-964f-e63cd9c041d5 | 2023-03-30 | Warnings | 9ad8885f-e450-43ad-964f-e63cd9c041d5 |
Adverse event summaries are temporarily unavailable. Other product information remains available.