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| Product NDC Code | 82929-010 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Samnyte 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 | CUTANEOUS | ||||||||
| Dosage Form | EMULSION | ||||||||
| RxCUI drug identifier | 1534792 | ||||||||
| Application Number | M015 | ||||||||
| Labeler Name | Sainite Trading Shenzhen Co., Ltd. | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients 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.Directions Adults and Children 12 years and older: When practical, cleanse the affected area with mild soap and warm water and rinse thotoughly. Gently dry by patting or blotting with toilet tissue or a soft cloth, before application of this product. Apply externally to the affected area uo to 6 times daily.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients 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.Uses 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.Purpose Topical Anesthetic
Spl product data elements
Usually a list of ingredients in a drug product.SAMNYTE Tattoo Numbing Cream Lidocaine WATER CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE TROLAMINE ALOE VERA WHOLE PROPYLENE GLYCOL MENTHOL LIDOCAINE LIDOCAINE .ALPHA.-TOCOPHEROL ACETATE LECITHIN, SOYBEAN
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.30ml / 1.06 Fl.Oz 82929-010-01
40ml / 1.41 Fl.Oz 82929-010-02
60ml / 2.12 Fl.Oz 82929-010-03
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 this product 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.Keep out of reach of children 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.Stop use and ask a doctor if Condition worsens, or does not imprcve within 7 days. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treateddoes 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.When using this product Do not exceed the recommended daily dosage unless directed by a doctor Do not put into the rectum by using fingers or any mechanical device or applicator.
Storage and handling
Information about safe storage and handling of the drug product.Other Informatiom ● 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.Warnings For external use only Do not this product Pregnant or breastfeeding, ask a health professional before use. When using this product Do not exceed the recommended daily dosage unless directed by a doctor Do not put into the rectum by using fingers or any mechanical device or applicator. Stop use and ask a doctor if Condition worsens, or does not imprcve within 7 days. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treateddoes not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Discontinue use Keep out of reach of children In case of accidental ingestion, seek madical attention immediately
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