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| Product NDC Code | 83596-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Adellina tattoo numbing |
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| Type | Brand | ||||
| Pharm Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 1534792 | ||||
| Application Number | M017 | ||||
| Labeler Name | Aramode | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient(s) Lidocaine 5% g/g. Purpose: Local Anesthetic
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use For the physical or local anesthesia associated with tattoo
Purpose
Information about the drug product’s indications for use.Purpose Local Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Adellina TATTOO NUMBING Lidocaine WATER PROPYLENE GLYCOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE GLYCERIN EDETATE DISODIUM HYDROXYACETOPHENONE 1,2-HEXANEDIOL MENTHA ARVENSIS LEAF CHRYSANTHELLUM INDICUM TOP PURSLANE POLYOXYL 40 HYDROGENATED CASTOR OIL LIDOCAINE LIDOCAINE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Package Label - Principal Display Panel 50g NDC: 83596-001-01 image description
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children In case of accidental ingestion, seek medical help immediately.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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.
Storage and handling
Information about safe storage and handling of the drug product.Storage and Handling: Keep away from direct sunlight or heat. Store at room temperature 15°-30℃(59-86°F). Protect from freezing.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API