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  5. Label Information: Dermoplast Pain Relieving

FDA Label for Dermoplast Pain Relieving

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS?
    12. PACKAGE LABELING:

Dermoplast Pain Relieving Product Label

The following document was submitted to the FDA by the labeler of this product Advantice Health. 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



Benzocaine 20%

Menthol 0.5%


Purpose



Topical analgesic


Uses



for temporary relief of pain and itching associated with • sunburn • insect bites • minor cuts • minor burns • minor skin irritations 


Warnings



For external use only

Flammable do not use near heat, flame, or fire or while smoking

Allergy alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.


When Using This Product



  • avoid contact with eyes. Do not spray in the face of mouth.
  • use only as directed
  • intentional misuse by deliberately concentrating or inhaling the contents can be harmful or fatal 
  • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

Stop Use And Ask A Doctor If



  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • itching, rash or irritation develops

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions



 Adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily
 Children under 2 years of age  consult a doctor  
  • to use this product, hold the can 6 to 12 inches away from the affected area. Direct spray nozzle towards skin and press button to activate spray.
  • to apply to face, spray in palm of hand and gently apply

Other Information



  • avoid contact with leather, fabric and upholstery to prevent possible staining or discoloration 
  • store at 20-25°C (68-77°F)

Inactive Ingredients



acetylated lanoline alcohol, aloe vera gel (decolorized), butane, cetyl acetate, hydrofluorocarbon 152a, methylparaben, PEG-400 monolaurate, polysorbate 85


Questions?



1-800-345-0032 Mon - Fri 8AM- 5PM EST Dermoplast.com


Package Labeling:



Label - Label

Label - Label


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