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| Product NDC Code | 82617-103 | ||||
|---|---|---|---|---|---|
| Drug Name | Black label b 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 | SPRAY | ||||
| RxCUI drug identifier | 2624687 | ||||
| Application Number | M015 | ||||
| Labeler Name | SCALP TECH 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 HCL 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 OVER CLEANSE THE AFFECTED AREA WITH MILD SOAP AND WARM WATER RINSE WELL OR PAT WITH AN APPROPRIATE CLEANSING PAD GENTLY DRY BY PATTING OR BLOTTING WITH TOILET TISSUE OR A SOFT CLOTH BEFORE APPLYING THIS PRODUCT USE SPRAY PUMP TO APPLY EXTERNALLY TO THE AFFECTED AREA UP TO 4 TIMES DAILY DO NOT USE MORE OFTEN THAN DIRECTED
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS AQUA, ETHOXYDIGLYCOL, PHENOXYETHANOL, ALLANTOIN, ETHYLHEXYLGLYCERIN
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 SYMPTOMS DUE TO HEMORRHOIDS, HEMORRHOIDAL TISSUES OR PILES: ITCHING PAIN SORENESS BURNING
Purpose
Information about the drug product’s indications for use.PURPOSE LOCAL ANESTHETIC
Spl product data elements
Usually a list of ingredients in a drug product.BLACK LABEL B NUMB LIDOCAINE HYDROCHLORIDE PHENOXYETHANOL DIETHYLENE GLYCOL MONOETHYL ETHER WATER ALLANTOIN ETHYLHEXYLGLYCERIN LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS
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.black
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. IF SWALLOWED, CALL A POISON CONTROL CENTER OR GET MEDICAL HELP RIGHT AWAY.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS? 1 (800) 611-7720
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION STORE AT ROOM TEMPERATURE (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. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU HAVE HEART DISEASE HIGH BLOOD PLESSURE THYROID DISEASE DIABETES DIFFICULTY IN URINATION TAKE MEDICINE FOR HIGH BLOOD PRESSURE DEPRESSION WHEN USING THIS PRODUCT DO NOT PUT INTO THE RECTUM BY USING FINGERS OR ANY MECHANICAL DEVICE OR APPLICATOR. STOP USE AND ASK A DOCTOR IF BLEEDING OCCURS CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS REDNESS, IRRITATION, SWELLING, PAIN OR OTHER SYMPTOMS OCCUR YOU EXPERIENCE WEAKNESS CONFUSION HEADACHE DIFFICULTY BREATHING PALE, GREY OR BLUE COLOURED SKIN. THESE MIGHT BE SIGNS OF METHEMOGLOBINEMIA, A RARE DISORDER, WHICH MAY APPEAR UP TO 2 HOURS AFTER USE.
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