FDA Label for Secondary Numb Lidocaine Phenylephrine Gel

View Indications, Usage & Precautions

Secondary Numb Lidocaine Phenylephrine Gel Product Label

The following document was submitted to the FDA by the labeler of this product Lalani Rx Consulting, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients (W/W)



Lidocaine 5%
Phenylephrine HCL 0.25%


Purpose



Local Anesthetic

Vaso Constrictor


Uses



• Temporary relief of pain
• Temporarily shrinks hemorrhoidal tissue
• For the temporary relief of anorectal discomfort associated with hemorrhoids


Warnings



For external use only


Do Not Use



if you have ▪ heart disease ▪ high blood pressure ▪ thyroid disease ▪ diabetes ▪ difficuly in urination


Ask A Doctor Before Use If You Are



• presently taking medicine for high blood pressure or depression


When Using This Product



• do not put it 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. If allergic  reaction to product occurs.


Keep Out Of Reach Of Children.



If swallowed, call poison control centre or get medical help right away


Directions



Adults and children 12 years and over:
• Children under 12 consult a doctor
• 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
• Apply to the affected area up to 3 times daily
• Do not use more often than directed


Inactive Ingredients



Aminomethylpropanol, Aqua, Benzyl Alcohol, Caprylyl Glycol, Carbomer, Phenoxyethanol, Propylene Glycol


Questions?



1-844-782-2387


Package Labeling:




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