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  5. Label Information: Comfort Candy Hemorrhoidal

FDA Label for Comfort Candy Hemorrhoidal

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENTS
    3. PURPOSE
    4. USES
    5. WARNINGS:
    6. DO NOT
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR
    9. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    10. KEEP OUT OF REACH OF CHILDREN.
    11. IF PREGNANT OR BREAST-FEEDING ,
    12. DIRECTIONS:
    13. OTHER INFORMATION:
    14. INACTIVE INGREDIENTS:
    15. QUESTIONS?
    16. PACKAGE LABELING:

Comfort Candy Hemorrhoidal Product Label

The following document was submitted to the FDA by the labeler of this product Bowler Esthetics, 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.

Drug Facts




Active Ingredients



Lidocaine 5.00 %
Phenylephrine Hcl 0.25%


Purpose



Anorectal (hemorrhoidal)
Anorectal (vasoconstrictor)


Uses



  • For the temporary relief of pain, irritation, or burning.

Warnings:



For external use only


Do Not



  • exceed the recommended daily dosage unless directed by a doctor. 
  • put this product into the rectum by using your fingers or any mechanical device or applicator. 
  • use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate glad unless directed by a doctor.

When Using This Product



  • If the condition worsens or does not improve within 7 days, consult a doctor. 
  • In case of bleeding, consult a doctor promptly.

Stop Use And Ask A Doctor



  • If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Ask A Doctor Or Pharmacist Before Use If You Are



  • presently taking a prescription drug for high blood pressure or depression.

    • Allergy alert


    • Certain persons can develop allergic reactions to ingredients in this product.

Keep Out Of Reach Of Children.



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


If Pregnant Or Breast-Feeding ,



ask a health professional before use.


Directions:



Adults:

  • When practical, cleanse the affected area with mild soap and warm water and rinse by patting or blotting with an appropriate cleansing pad. 
  • Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product.
  • Children under 12 years of age: consult a doctor.

Other Information:



  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:



Alcohol, Allantoin, Aloe Barbadensis Leaf Juice, Citric Acid, Dimethyl Sulfone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Water (Aqua), Xanthan Gum


Questions?



(435-295-4328)


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