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| Product NDC Code | 80069-014 | ||||
|---|---|---|---|---|---|
| Drug Name | Zone 1 |
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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 | 1010895 | ||||
| Application Number | M015 | ||||
| Labeler Name | Dermal Source, 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 Ingredients (in each cc) Purpose Lidocaine HCl 4% Topical Anesthetic
| Lidocaine HCl 4% | Topical Anesthetic |
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: Sensitivity test advised prior to use. Apply a moderately thick layer of cream to intact skin. Discontinue use if sensitivity occurs. Wait for numbness to develop. For thinner skin (eye area) wait 10-15 minutes. For thicker skin, best results are obtained after 1 hour of application. Cleanse area thoroughly before procedure.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Purified Water, Glyceryl Stearate (and) PEG 100-Stearate, Petrolatum, Stearic Acid, Cetyl Alcohol, Xanthan Gum, Glycerol Monostearate, Sodium Hydroxymethlyglycinate, Triethanolamine, Propyl Paraben, Methyl Paraben, and BHT.
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.Indications: Temporarily relieves pain associated with anorectal disorders.
Purpose
Information about the drug product’s indications for use.Active Ingredients (in each cc) Purpose Lidocaine HCl 4% Topical Anesthetic
| Lidocaine HCl 4% | Topical Anesthetic |
Spl product data elements
Usually a list of ingredients in a drug product.Zone 1 Lidocaine HCl Lidocaine Hydrochloride Lidocaine Lidocaine Hydrochloride Anhydrous Water Glyceryl Monostearate Peg-100 Stearate Petrolatum Stearic Acid Cetyl Alcohol Xanthan Gum Sodium Hydroxymethylglycinate Trolamine Propylparaben Methylparaben Butylated Hydroxytoluene label
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 MAXIMUM Zone 1 TOPICAL ANALGESIC 7 pH 1/2 oz . 4% Lidocaine Cream for use before a pain sensitive procedure Distributed by: DERMAL SOURCE Portland, OR 97232 www.dermalsource.com 1-866-568-3223 NDC 80069-014-01
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 if pregnant or breast-feeding. Do not use if you have seizures or liver disease. Do not use if you have a known allergy or sensitivity to any component of this product. If sensitivity occurs, discontinue use, immediately cleanse skin and seek medical attention. If condition worsens or if symptoms persist for more than seven days or clear up and occur again, discontinue use and consult a doctor. Do not use in large quantities, particularly over raw surfaces or blistered areas. Avoid contact with eyes. In case of contact with eyes, rinse immediately with copious amounts of eyewash and seek treatment by a medical professional. If accidentally swallowed, get medical attention immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Contact distributor on product label for further questions.
Storage and handling
Information about safe storage and handling of the drug product.Other information: Store in a cool dark place or refrigerate. Discard by expiration date.
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: Do not swallow. Keep out of children's reach. External use only on intact skin.
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