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Product NDC Code | 82739-014 | ||||||||
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Drug Name | Aobbiy tattoo numbing cream |
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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 | M016 | ||||||||
Labeler Name | Shenzhen Situya Trading Co., Ltd. | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient LIDOCAINE 5%
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.Correct Use Steps Before Tattooing 1. Clean your hands and the treatment area with soft soap and warm water, rinse thoroughly, then gently pat dry. 2. Apply a thick layer of the numbing cream onto the treatment area. 3. Wrap tightly with plastic wrap and wait 45-60 minutes for the numbness to peak. (The peak lasts up to 6 hours.) 4. Wipe away the residue with a soft cloth or tissue. 5. Begin the procedure.
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 Apply up to 3 times a day. Children (under 12 years of age): consult a doctor. Adults: before applying this product, clean the affected area with mild soap and warm water and rinse thoroughly. Pat dry the area with a soft cloth or tissue.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aqua, Propylene Glycol, Carbomer 934, Lecithin (Soybean), Tocopheryl Acetate, Benzyl Alcohol.
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 temporarily relieves local and anorectal discomfort associated with the anorectal disorder or swelling.
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.AOBBIY Tattoo Numbing Cream Tattoo Numbing Cream CARBOMER 934 WATER LIDOCAINE LIDOCAINE PROPYLENE GLYCOL LECITHIN, SOYBEAN .ALPHA.-TOCOPHEROL ACETATE BENZYL ALCOHOL
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.PRINCIPAL DISPLAY PANEL 2
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 pregnant or breastfeeding, ask your doctor before use. in case of accidental overdose, seek immediate medical help or contact the Poison Control Center. 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 Oot Of Reach Of Children In case of accidental ingestion, seek medical help right away.
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 the symptom being treated does not improve, or if redness, irritation, swelling, pain, or other symptoms appear or worsen. Seek medical help right away.
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 do not exceed the recommended daily dosage unless directed by a doctor. Certain sensitive individuals may have an allergic reaction to some of the ingredients of this product. do not put this cream into the rectum using your fingers, applicators, or any medical devices.
Storage and handling
Information about safe storage and handling of the drug product.Other information Keep away from direct sunlight or heat. Store at room temperature 59°-86°F (15°-30°C).
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.
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