1. Home
  2. Labeler Index
  3. Nivagen Pharmaceuticals, Inc.
  4. 75834-113
  5. Label Information: Lidocaine

FDA Label for Lidocaine

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - WHEN USING
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS?
    13. PRINCIPAL DISPLAY PANEL - 30 G TUBE CARTON

Lidocaine Product Label

The following document was submitted to the FDA by the labeler of this product Nivagen Pharmaceuticals, 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.

Other



Drug Facts


Active Ingredient



Lidocaine 5% w/w


Purpose



Local anesthetic


Uses



Helps relieve the pain, itching, and burningassociated with hemorrhoids and other anorectal disorders.


Warnings



For external use only.


Otc - When Using



When using this product

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

Stop Use And Ask A 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 subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and return within a few days

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • 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 soft cloth before applying.
  • Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
  • Children under 12 years of age: consult a doctor.
  • To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.

Other Information



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


Inactive Ingredients



benzyl alcohol,carbomer hompolymer type C, C10-18 triglycerides, cholesterol, lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopherol, trolamine, water


Questions?



1-877-977-0687


Principal Display Panel - 30 G Tube Carton



NDC 75834-113-30

Lidocaine 5%
Anorectal Cream

Relieves:

* Please review the disclaimer below.