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| Product NDC Code | 83364-010 | ||||
|---|---|---|---|---|---|
| Drug Name | Healcome tattoo numbing cream 5% lidocaine |
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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 | YITONGBADA (SHENZHEN) INTERNATIONAL TRADE 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 - Patch Test Warning: Before first use, apply a small amount of cream to a small area of skin and wait 24 hours. If no adverse reaction occurs, proceed with regular use. - Clean and dry skin with mild soap. - Apply a thick, even layer with brush. - Wrap in plastic for 30 minutes. - Wipe off with tissue before starting the procedure. - Numbness duration may vary with temperature and skin type. If it's weak after 30 minutes, extend it to 60 minutes. Children under 12 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Polyethylene Glycol, Soybean Lecithin, .Alpha.-Tocopherol Acetate, Water, Carbomer 934, 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.Uses - Temporarily relieves pain, burning, and soreness - Commonly used for tattooing, waxing, piercing, injection, microneedling, and hair removal Do not use - in large quantities - on wounds or on irritated or damaged skin - with a heating pad When using this product - avoid contact with eyes. If product gets into the eye, flush with water for 15 minutes - use only as directed - do not bandage tightly - avoid contact with eyes and mucous membranes - do not expose the area to local heat or to direct sunlight Stop and ask a doctor if discomfort persists. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.
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.Healcome Tattoo Numbing Cream 5% Lidocaine LIDOCAINE PROPYLENE GLYCOL CARBOMER 934 .ALPHA.-TOCOPHEROL ACETATE WATER BENZYL ALCOHOL LIDOCAINE LIDOCAINE SOYBEAN LECITHIN
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.Drug Facts HC02 Drug Facts Active ingredients Lidocaine 5% Topical Anesthetic Uses - Temporarily relieves pain, burning, and soreness - Commonly used for tattooing, waxing, piercing, injection, microneedling, and hair removal Do not use - in large quantities - on wounds or on irritated or damaged skin - with a heating pad When using this product - avoid contact with eyes. If product gets into the eye, flush with water for 15 minutes - use only as directed - do not bandage tightly - avoid contact with eyes and mucous membranes - do not expose the area to local heat or to direct sunlight Stop and ask a doctor if discomfort persists. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away. Warnings For external use only Directions - Patch Test Warning: Before first use, apply a small amount of cream to a small area of skin and wait 24 hours. If no adverse reaction occurs, proceed with regular use. - Clean and dry skin with mild soap. - Apply a thick, even layer with brush. - Wrap in plastic for 30 minutes. - Wipe off with tissue before starting the procedure. - Numbness duration may vary with temperature and skin type. If it's weak after 30 minutes, extend it to 60 minutes. Children under 12 years of age: ask a doctor Other information Store at room temperature, away from heat and moisture. ALWAYS CLOSE CAP TIGHTLY AFTER USE Inactive ingredients Polyethylene Glycol, Soybean Lecithin, .Alpha.-Tocopherol Acetate, Water, Carbomer 934, Benzyl Alcohol
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Stop and ask a doctor if discomfort persists.
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 - in large quantities - on wounds or on irritated or damaged skin - with a heating pad
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 advice immediately or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Store at room temperature, away from heat and moisture. ALWAYS CLOSE CAP TIGHTLY AFTER 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 - avoid contact with eyes. If product gets into the eye, flush with water for 15 minutes - use only as directed - do not bandage tightly - avoid contact with eyes and mucous membranes - do not expose the area to local heat or to direct sunlight
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding, ask a health professional before use.
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