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  5. Label Information: Numb520

FDA Label for Numb520

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    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. KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. 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 Ingredient



Lidocaine 5%


Purpose



Local Anesthetic


Uses:



Temporarily relieves pain, itching, or swelling associated with anorectal disorders.


Warnings



(For external use only)


Do Not Use This Product If



  • Pregnant or breastfeeding, ask a health professional before use
  • Tamper-evident shrink band around the container is broken.

When Using This Product



  • Do not exceed the recommended daily unless directed by a doctor.
  • 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.
  • In case of accidental overdose, contact a doctor or Poison Control Center immediately. 

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.


Keep Out Of Reach Of Children



In case of accidental ingestion, seek medical attention immediately.


Directions



  • Sensitivity test advised prior to use. Apply sparingly to affected area after thoroughly cleansing. Wait until anesthetic effect occurs (90 seconds). You may reapply to continue numbing effect.
  • Apply up to 6 times a day.
  • Children under 12 year 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



Water, Aloe Barbadensis (Aloe Vera) Leaf Juice, Propylene Glycol, Benzyl Alcohol, Epinephrine HCL, Citric Acid, Disodium EDTA, Cholesterol, Sodium Metabisulfite, Lecithin, Polysorbate 80, Phenoxyethanol


Package Labeling:



Label - Label

Label - Label


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