miaderm-L

Manufacturer
Aiden Industries LLC
Effective date
2021-01-28
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 22:54:30

Label at a glance#

Productmiaderm-L radiation relief
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

For the temporary relief of pain, irritation and itching associated with radiation dermatitis, mild burns, and sunburn.

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

LIDOCAINE HCL 4%

PURPOSE

OTC - PURPOSE SECTION

TOPICAL ANALGESIC/ANESTHETIC

USES

INDICATIONS & USAGE SECTION

  • For the temporary relief of pain, irritation and itching associated with radiation dermatitis, mild burns, and sunburn.

WARNINGS

WARNINGS SECTION

  • For external use only.
  • Avoid contact with the eyes.
  • If contact occurs, rinsethoroughly with cool water.
  • In case of ingestion call Poison Control or contact your physician.
  • Do not use: on open wounds, cuts, infected skin, mouth, genitals, or mucous membranes.
  • Do not use: if you are allergic to any other type of numbing medication.
  • Do not use: if taking Class I antiarrhythmic drugs (such as Tocainide and Mexiletine).
  • Consult your physician for children under 13 years.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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.

OTHER INFORMATION

OTHER SAFETY INFORMATION

  • Store at 77°F: (25°C); excursions permitted to 59° - 86°F: (15°-30°C). Protect from freezing. Keep lid tightly closed.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

32069 Label MiadermL 4oz 05181532069 Label MiadermL 4oz 051815

FDA-Initiated Inactive NDC Indexing#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71320-20071320-200-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f820ca4e-b093-bd2e-e053-6394a90a6ff19ad8885f-e450-43ad-964f-e63cd9c041d52023-03-30WarningsExact identifier
spl set id: 9ad8885f-e450-43ad-964f-e63cd9c041d5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.