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| Product NDC Code | 69903-003 | ||||
|---|---|---|---|---|---|
| Drug Name | Dr. numb |
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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 | ||||
| Application Number | M016 | ||||
| Labeler Name | Shinpharma Inc | ||||
| 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 ingredient Lidocaine 4% w/w
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 2 years and older: Apply externally to the affected area up to 3 to 4 times a day Children under 2 years: Consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Benzyl Alcohol, Carbopol, Lecithin(Soybean), Propylene Glycol, Tocopheryl Acetate, 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.Uses Temporarily relieves pain and itching due to insect bites minor burns minor cuts minor scrapes minor skin irritations sunburn
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.Dr. Numb Lidocaine PROPYLENE GLYCOL BUTYL ETHER TOCOPHERYL RETINOATE WATER LIDOCAINE LIDOCAINE BENZYL ALCOHOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE 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.Principal Display Panel NDC 69903-003-30 Water-based, Hypoallergenic and Fast Penetrating Topical Pain Relief and Anti-Itch Formula Apply to the skin to relieve pain FOR EXTERNAL USE ONLY Dr. Numb TOPICAL ANESTHETIC CREAM Lidocaine 4% Cream - Topical Anesthetic 30g Label
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 OUR OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Question or Comments Contact our dedicated Customer Care at +1(877) 786 2001 or email us at [email protected]
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 the use and consult doctor if allergic reaction occurs condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase
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 the eyes do not use in large quantities, particularly over raw surfaces or blistered areas
Storage and handling
Information about safe storage and handling of the drug product.Other Information May be applied under occlusive dressing. Store at 25 ̊C (77 ̊F); excursions permitted to 15°C -30°C (59°F - 86°F) [see USP Controlled Room Temperature].
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 When using this product avoid contact with the eyes do not use in large quantities, particularly over raw surfaces or blistered areas Stop the use and consult doctor if allergic reaction occurs condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase KEEP OUR OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away
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