MYDERM ALOE AND LIDOCAINE- lidocaine gel

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Lidocaine ............. 0.5%

PURPOSE

Lidocaine 0.5% ............. Pain Reliever

INDICATIONS & USAGE

Temporary relief of pain and itching due to

- sunburn - minor burn - insect bites - minor cuts - scraps

WARNINGS

Warnings

For external use only

When using this product keep out of eyes

Rinse with warter to remove

STOP USE

Sop use and ask a doctor

system persist for more than 7 days.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

DOSAGE & ADMINISTRATION

Direction

Adults and children 2 years and older: aooly to affected area not more that 3-4 times a day

Children under 2 years of age: consult a physician.

INACTIVE INGREDIENT

Inactive Ingredients: Aloe Barbadensis Leaf Extract, Carbomer, Diazolidinyl Urea, Disodium EDTA, Glycerin, Isopropyl Alcohol, Menthol, Polysorbate 80, Propylene Glycol, Triethanolamine, Water, Yellow 5.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MYDERM ALOE AND LIDOCAINE 
lidocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
MENTHOL (UNII: L7T10EIP3A)
PROPYLENE GLYCOL 2-STEARATE (UNII: 5317AOR1RX)
TROLAMINE SALICYLATE (UNII: H8O4040BHD)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER 1342 (UNII: 809Y72KV36)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
DISODIUM HEDTA (UNII: KME849MC7A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
FD&C YELLOW NO. 5 FREE ACID (UNII: 6TP696149N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-037-09	592 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/26/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/26/2019

Labeler - Medline Industries (025460908)

Registrant - Inspec Solutions LLC. (081030372)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions LLC.		081030372	manufacture(53329-037)