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  5. Label Information: Rectasmoothe

FDA Label for Rectasmoothe

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS:
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK DOCTOR IF
    7. KEEP OUT OF THE REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS

Rectasmoothe Product Label

The following document was submitted to the FDA by the labeler of this product Leading Pharma, Llc. 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% w/w


Purpose



Local anesthetic


Uses



Helps relive the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.


Warnings:



For external use only.


When Using This Product



  • avoid contact with the eyes
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any other mechanical device or applicator


Stop Use And Ask Doctor If



  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs to ingredients in this product
  • symptom being treated does not suside or if redness, irritation swelling, pain or other symptoms develop or increase
  • symptoms clear up and return within a few days

Keep Out Of The Reach Of Children



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


Directions



  • When practical, clean area with mild soap and warm water and rinse thouroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
  • Adults and children 12 years and older: Apply externally to the affected area up to six times a day.
  • Children under 12 years of age: Consult a doctor
  • To use finger cots: Roll one finger cot over finger. FGently squeeze cream onto finger cot. Smooth a layer of the cream over the affected area.

Other Information



Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].


Inactive Ingredients



cetyl alcohol, glyceryl monostearate SE, methylparaben, propylene glycol, propylparaben, purified water, white petrolatum, white wax


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