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| Product NDC Code | 55621-011 | ||||
|---|---|---|---|---|---|
| Drug Name | Assured bikini smooth 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 | 1432482 | ||||
| Application Number | M015 | ||||
| Labeler Name | Zhejiang Jingwei Pharmaceutical 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 2.00 %
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 over 12 years of age: -immediately after hair removal, apply sparingly and only to the areas where it is needed -Repeat as necessary, but no more than 4 times daily -Continue to apply as a regular part of your hair removal routine, whether you use a razor, wax or depilatory
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.aloe barbadensis leaf juice, carbomer Inactive Ingredients 940, ethyl alcohol, ethylparaben, glycerin, menthol, propanediol, triethanolamine, water
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.temporarily relieves pain, itching and irritation. Uses
Purpose
Information about the drug product’s indications for use.Purpose Topical analgesic
Spl product data elements
Usually a list of ingredients in a drug product.Assured Bikini Smooth Cream LIDOCAINE CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) ALCOHOL ETHYLPARABEN TROLAMINE GLYCERIN MENTHOL, UNSPECIFIED FORM MALONDIALDEHYDE ALOE VERA LEAF WATER 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.copy of label
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 -before any hair removal process that involves heat or lasers -in large quantities, particularly over raw surfaces or blistered areas
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, get Keep out of reach of children medical help or contact a Poison Control Center 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 and ask a doctor if -symptoms persist for more than 7 days or clear up and occur again within a few days -condition worsens -redness is present -irritation develops
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 -use only as directed
Storage and handling
Information about safe storage and handling of the drug product.store at room temperature 59 - 86 F Other information (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