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  5. Label Information: Numb520

FDA Label for Numb520

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES:
    4. WARNINGS
    5. DO NOT USE THIS PRODUCT IF
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. PACKAGE LABELING:

Numb520 Product Label

The following document was submitted to the FDA by the labeler of this product Clinical Resolution Laboratory, 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



Lidocaine HCL 5%

Phenylephrine HCL, 0.25%


Purpose



Local Anesthetic

Vasoconstrictor


Uses:



For the temporary relief of local and anorectal itching, discomfort, and pain associated with anorectal disorders or anorectal inflammation.


Warnings



  • for external use only.
  • avoid contact with the eyes.

Do Not Use This Product If



  • pregnant or breastfeeding, ask a health professional before use.
  • Tamper Evident "Do not use this product" if safety seal is broken or missing.
  • you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of prostate gland unless directed by a doctor.

When Using This Product



  • do not exceed the recommended daily usage.
  • certain persons can develop allergic reactions to ingredients in this product.
  • do not put this product into the rectum by using fingers or any medical device or applicator.
  • if swallowed, call your Poison Control Center at 1(800) 222-1222.
  • if condition worsens or does not improve within 7 days, consult a doctor.

Stop Use And Ask A Doctor If



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

Directions



  • clean the affected area.
  • sensitivity and possible allergy tests advised prior to use. Spray spraingly to affected area after thoroughly cleansing. Wait until anesthetic effect occurs. You may reapply to continue numbing effect.
  • apply to the affected area up to 4 times daily.
  • children under 12 years of age, consult a doctor.

Other Information



  • keep away from direct sunlight or heat.
  • store in room temperature (59-86°F / 15-30°C).

Inactive Ingredients



Allantoin, Arginine, Benzyl Alcohol, Disodium EDTA, Ethoxydiglycol, Phenoxyethanol, Polysorbate 20, Purified Water, Sodium Benzoate, Sodium Sulfite


Package Labeling:



Label - Label

Label - Label


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