MYDERM- lidocaine gel 
Inspec Solutions 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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MyDerm Pain Reliever Aloe Gel Lidocaine HCI 0.5%

Active Ingredient

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

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

Temporary relief of pain and itching due to

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

Warnings

For external use only

When using this product keep out of eyes

Rinse with warter to remove

Sop use and ask a doctor

system persist for more than 7 days.

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

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

Pain Reliever ALOE GEL Lidocain HCI 0.5%

MYDERM 
lidocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72667-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72667-008-01237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/26/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/26/2019
Labeler - Inspec Solutions LLC. (081030372)
Establishment
NameAddressID/FEIBusiness Operations
Inspec Solutions LLC.081030372manufacture(72667-008)

Revised: 1/2023
Document Id: f1ec87b6-3897-1d10-e053-2995a90a053d
Set id: 82d075d1-c92e-2097-e053-2991aa0ab131
Version: 3
Effective Time: 20230110
 
Inspec Solutions LLC.