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Product NDC Code | 84023-201 | ||||
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Drug Name | 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 | PASTE | ||||
Application Number | M017 | ||||
Labeler Name | Shenzhen Yangan Technology Co., Ltd. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Lidocaine 5%
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.Adults and Children 12 years and older: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth, before application of this product. Apply externally to the affected area up to 6 times daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Aloe barbadebsis leaf juice (Aloe vera) Water Lecithin (Soybean) Propylene Glycol Tocopheryl Acetate Carbomer Menthol Triethanolamine
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.For temporary relief of local discomfort, itching, pain, soreness, or burning in the perianal area associated with anorectal disorders.
Purpose
Information about the drug product’s indications for use.Topical Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.Tattoo Numbing Cream Lidocaine ALOE LECITHIN, SOYBEAN PROPYLENE GLYCOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE TROLAMINE MENTHOL LIDOCAINE LIDOCAINE WATER ALPHA-TOCOPHEROL ACETATE
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.label4 label5
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Tattoo Numbing Cream
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.Pregnant or breastfeeding, ask a health professional before use.
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.In case of accidental ingestion, seek madical attention 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.Condition worsens, or does not improve within 7 days. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation,swelling, pain, or other symptoms develop or increase, discontinue use.
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.Do not exceed the recommended daily dosage unless directed by a doctor. Do not put into the rectum by using fingers or any medical device or applicator.
Storage and handling
Information about safe storage and handling of the drug product.Keep away from direct sunlight or heat. Store in 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.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