FDA Label for Dermoplast Sunburn And Burn Relief

View Indications, Usage & Precautions

Dermoplast Sunburn And Burn Relief Product Label

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

Distributed by Advantice Health, LLC
Cedar Knolls, NJ 07927


Otc - Purpose



Active ingredientsPurpose
Benzocaine 20%Topical analgesic
Menthol 0.5%Topical analgesic

Uses



for temporary relief of pain and itching associated with

  • sunburn
  • insect bites
  • minor cuts
  • scrapes
  • 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 or 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

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



Adults and children 2 years of age and olderapply to affected area not more than 3 to 4 times daily
Children under 2 years of ageconsult 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 lanolin 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


Principal Display Panel - 78 G Can Label



Dermoplast®
Pain Relieving Spray

HOSPITAL TRUSTED BRAND

SUNBURN &
BURN RELIEF

RELIEVES PAIN & ITCH
from sunburns, minor burns
& other skin irritations

#1 Doctor Recommended Brand*

Provides Fast
Pain Relief

Menthol Cools
& Comforts

Soothing Aloe
& Lanolin

NET WT. 2.75 oz (78 g)


* Please review the disclaimer below.