ADELLINA TATTOO NUMBING- lidocaine cream 
Aramode

----------

Active Ingredient(s)

Lidocaine 5% g/g. Purpose: Local Anesthetic

Purpose

Local Anesthetic

Use

For the physical or local anesthesia associated with tattoo

Warnings

For external use only.Avoid contact with the eyes Keepaway from heat or flame. Do not use in large quantities,particularly over raw surfaces or blistered areas.

Do not use

When using this product

When using this product do not exceed the recommended dailydosage unless directed by a doctor. certain persons can developallergic reactions to ingredients in this product. do not put thisproduct into the rectum by using finger.

Stop use and ask a doctor if

Stop use and ask a doctor if redness, irritation, swelling, pain,or other symptoms occurs,or lf condition worsens, or if symptomspersist for more than 7 days or clear up and occur again within afew days.

Keep out of reach of children

In case of accidental ingestion, seek medical help immediately.

Directions

Adults: Clean the affected area with mild soap and warm waterand rinse thoroughly.Gently dry by patting with toilet tissue or asoft cloth before application of this product.
Children under 12 years of age: consult a doctor.

Storage and Handling:

Inactive ingredients

AQUA, Propylene glycol, Carbomer, Glycerin, Disodium edta,Hydroxyacetophenone,1,2-Hexanediol, Mentha Arvensis LeafExtract, Chrysanthellum Indicum Extract, Portulaca OleraceaExtract, PEG-40 hydrogenated castor oil

Package Label - Principal Display Panel

image description50g NDC: 83596-001-01

ADELLINA TATTOO NUMBING 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83596-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
MENTHA ARVENSIS LEAF (UNII: A4IWO4DDZ9)  
CHRYSANTHELLUM INDICUM TOP (UNII: STJ856D1Z0)  
PURSLANE (UNII: M6S840WXG5)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83596-001-011 in 1 PACKAGE07/28/2023
150 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01707/28/2023
Labeler - Aramode (963192477)
Registrant - Aramode (963192477)
Establishment
NameAddressID/FEIBusiness Operations
Aramode963192477manufacture(83596-001)

Revised: 11/2023
Document Id: 0a3c025d-6a5d-b491-e063-6294a90a0373
Set id: 929a51b8-afa4-4756-9801-9136185f4104
Version: 2
Effective Time: 20231115
 
Aramode