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  5. Label Information: Vasocaine

FDA Label for Vasocaine

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - WHEN USING
    7. DOSAGE & ADMINISTRATION
    8. INACTIVE INGREDIENT
    9. STORAGE AND HANDLING
    10. OTC - QUESTIONS
    11. PRINCIPAL DISPLAY PANEL

Vasocaine Product Label

The following document was submitted to the FDA by the labeler of this product Dermal Source, 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.

Otc - Active Ingredient





Otc - Purpose



Active Ingredients Purpose
Lidocaine HCl   5% Topical Anesthetic
Epinephrine HCl.01% Vasoconstrictor

Indications & Usage



Uses: External Use Only.  
Temporarily relieves pain, itching or swelling associated with anorectal disorders or pain sensitive procedures.


Warnings



WARNINGS: Keep out of reach of children


Otc - Do Not Use



Do not use if you have

  • seizures or liver disease
  • if pregnant or breast feeding
  • a known allergy or sensitivity to any of the components of this product. If sensitivity occurs, discontinue use, and seek medical attention. If condition worsens or symptoms persist for more than seven days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. Do not use in large quantities, particularly over raw surfaces or blistered areas.

    • Avoid direct contact with eyes. If contact should occur, irrigate with copious amounts of sterile saline and seek medical attention. DO NOT SWALLOW. If you have swallowed this product seek medical attention immediately.


Otc - When Using



When using this product you may notice temporary blanching or redness of the skin where liquid is applied.


Dosage & Administration



Directions:  Sensitivity test advised prior to use.

Apply sparingly to affected area. Wait until anesthetic effect occurs (90 seconds). Discontinue use if sensitivity occurs. Wash Vasocaine off completely before tattooing.


Inactive Ingredient



Inactive Ingredients: Purified Water, Propylene Glycol, Sodium Metabisulfite, Citric Acid Diazolidinyl Urea, Methyl Paraben, Propyl Paraben, and Disodium EDTA.


Storage And Handling



Other information: Store in cool dark place or refrigerate and out of reach of children. Discard after expiration date.


Otc - Questions



Questions?
Contact distributor on product label.


Principal Display Panel



Vasocaine

Fast acting anesthetic to reduce pain and swelling

4 oz.

Distributed by: DERMAL SOURCE
Portland, OR 97232
www.dermalsource.com
1-866-568-3223


* Please review the disclaimer below.