Adellina Tattoo Numbing
FDA Label NDC 83596-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Aramode for the product Adellina Tattoo Numbing (NDC 83596-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient(s), purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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