FDA Label for Numb Plus Maximum Strength Anorectal

View Indications, Usage & Precautions

Numb Plus Maximum Strength Anorectal Product Label

The following document was submitted to the FDA by the labeler of this product Seenext Venture Ltd. 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 Ingredient



Lidocaine 5.00%


Purpose



Anorectal (Hermorrhoidal)


Uses



For temporary relief of local discomfort, itching, pain, soreness, or burning in the perianal area associated with anorectal disorders 


Warnings



For external use only


When Using This Product



  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop The Use And Consult Doctor If



  • allergic reaction occurs
  • rectal bleeding occurs
  • redness, irritation, swelling, pain, or other symptoms begin or increase
  • condition worsens or does not improve within 7 days

Keep Out Of Reach Of Children



If swallowed, get medical help or contact a Poison Control Center right away


If Pregnant Or Breastfeeding,



ask a health professional before use   


Directions



  • Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with tissue or a soft cloth before application of product
  • when first opening the jar, twist the cap and peel off the foil seal
  • apply externally to the affected area up to 6 times daily
  • children under 12 years of age: consult a doctor 

Other Information



  • always keep the jar tightly closed
  • protect from freezing
  • store at room temperatures not exceeding 59°F to 86°F (15°C to 30°C)

Inactive Ingredients



Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, Carbomer, Dimethyl Isosorbide, Dodecane, Ethylhexylglycerin, Lecithin, Phenoxyethanol, Propylene Glycol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Triethanolamine, Zemea (Corn) Propanediol


Questions Or Comments?



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