FDA Label for Hemorrhoid Relief Cream

View Indications, Usage & Precautions

Hemorrhoid Relief Cream Product Label

The following document was submitted to the FDA by the labeler of this product Alaina Healthcare Private Limited. 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.

Drug Facts Active Ingredient



Lidocaine 5% W/W


Purpose



Local Anesthetic


Uses



helps relieve the pain, itching, and burning, associated with hemorrhoids and anorectal disorders.


Warnings  For External Use Only



    When using this product 

  • use only as directed.
  • Avoid contact with eyes. 
  • do not exceed recommended dosage unless directed by a doctor. 
  • do not out this product into the rectum by using fingers or any mechanical device or applicator.

    Stop use and ask a doctor if 
  • rectal bleeding occurs. 
  • condition worsens or does not improve within 7 days. 
  • symptoms clear up and occur again within a few days. 
  • an allergic reaction develops to ingredients in this product. 
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.
    If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children



keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Directions



Adult and children 12 years and over:

  • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • apply externally to the affected area up to 6 times a day children under 12 years of age: consult a doctor.

Other Information.



  • Store between 15°-30° C (59°-30° F).

Inactive Ingredient



Benzyl Alcohol, Carbomer 940, Cholesterol, Isopropyl Myristate, Lecithin (Soya), Polysorbate 80, Propylene Glycol, Purified Water, Triethanolamine, Vitamin-E Acetate.


Questions Or Comments? 1-888-287-1915




Package Label.Principal Display Panel



Hemorrhoid Relief Cream-Tube - NDC 73492-712-28 - Label.

Hemorrhoid Relief Cream-Tube - NDC 73492-712-28 - Carton.


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