ADELLINA TATTOO NUMBING- lidocaine cream

Adellina TATTOO NUMBING by

Drug Labeling and Warnings

Adellina TATTOO NUMBING by is a Otc medication manufactured, distributed, or labeled by Aramode. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• Do not use if Pregnant or breastfeeding, ask a health professionalbefore use.In case of accidental overdose, get medical help or contactthe Poison Control Center immediately. Seal is broken or missing.

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:

• Keep away from direct sunlight or heat.
  Store at room temperature 15°-30℃(59-86°F).
• Protect from freezing.

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

50g NDC: 83596-001-01

INGREDIENTS AND APPEARANCE

ADELLINA TATTOO NUMBING 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83596-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83596-001-01	1 in 1 PACKAGE	07/28/2023
1		50 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/28/2023

Labeler - Aramode (963192477)

Registrant - Aramode (963192477)

Establishment
Name	Address	ID/FEI	Business Operations
Aramode		963192477	manufacture(83596-001)