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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 HCl 5%


Purpose



Local Anesthetic


Uses:



for the temporary relief of local and anorectal discomfort associated with anorectal disorders or inflammation.


Warnings



(For external use only)


Do Not Use This Product If



  • pregnant or breastfeeding, ask a health professional before use.
  • in case of accidental overdose, get medical help or contact the Poison Control Center immediately.
  • tamper evident "Do not use this product" if seal is broken or missing.

When Using This Product



  • do not exceed the recommended daily dosage 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 finger or any medical device or applicator.

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



  • Adults: 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 up to 6 times a day.
  • 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, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Dimethyl Isosorbide, Disodium EDTA, Hydrogenated Polydecene, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Propylene Glycol, Purified Water, Sodium Polyacrylate, Tocopheryl Acetate, Trideceth-6, Triethanolamine


Package Labeling:



Label - Label

Label - Label


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