FDA Label for Adellina Tattoo Numbing

View Indications, Usage & Precautions

Adellina Tattoo Numbing Product Label

The following document was submitted to the FDA by the labeler of this product Aramode. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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