MIADERM-L RADIATION RELIEF- lidocaine hydrochloride lotion 
Aiden Industries LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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AIDEN INDUSTRIES (as PLD) - MIADERM-L - RADIATION RELIEF (71320-200) - DELIST

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.

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

32069 Label MiadermL 4oz 051815

MIADERM-L  RADIATION RELIEF
lidocaine hydrochloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71320-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71320-200-06118 mL in 1 TUBE; Type 0: Not a Combination Product09/11/201812/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/13/201512/31/2020
Labeler - Aiden Industries LLC (022183598)

Revised: 3/2023
 
Aiden Industries LLC