MIADERM-L RADIATION RELIEF- lidocaine hydrochloride lotion

miaderm-L by

Drug Labeling and Warnings

miaderm-L by is a Otc medication manufactured, distributed, or labeled by Aiden Industries LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

LIDOCAINE HCL 4%

PURPOSE

TOPICAL ANALGESIC/ANESTHETIC

USES

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

WARNINGS

• 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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DIRECTIONS

• 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

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

INACTIVE INGREDIENTS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MIADERM-L  RADIATION RELIEF
lidocaine hydrochloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71320-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOPENTYLDIOL (UNII: 19NOL5474Q)
POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)
CETEARYL METHICONE (15000 MW) (UNII: VY9RTR7MSY)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
STEARYL PHOSPHATE (UNII: F3C8G3904Y)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71320-200-06	118 mL in 1 TUBE; Type 0: Not a Combination Product	09/11/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/13/2015

Labeler - Aiden Industries LLC (022183598)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources LLC		081239587	manufacture(71320-200)