FDA Label for Dermoplast First Aid

View Indications, Usage & Precautions

Dermoplast First Aid 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.

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Drug Facts

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.

Distributed by Moberg Pharma North
America LLC Cedar Knolls, NJ 07927


Otc - Purpose



Active ingredientsPurposes
Benzethonium chloride 0.2%First aid antiseptic
Benzocaine 20%Topical analgesic

Uses



first aid for the temporary relief of pain and itching and to help prevent infection in minor cuts, scrapes and burns


Warnings



For external use only


Do Not Use



  • in the eyes
  • over large areas of the body

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.

Ask A Doctor Before Use If You Have



  • deep or puncture wounds
  • animal bites
  • serious burns

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



  • clean the affected area
  • Adults and children 2 years of age and olderapply a small amount to affected area 1 to 3 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



aloe vera gel (decolorized), cyclomethicone, dipropylene glycol, isobutane, SD alcohol 40-B (73% v/v), tocopheryl acetate (vitamin E acetate)


Questions?



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


Principal Display Panel - 78 G Can Label



#1 Pharmacist Recommended Brand

Dermoplast®
Anitseptic
Anesthetic

FIRST AID
SPRAY
First Aid Antiseptic and Pain Reliever

HOSPITAL
STRENGTH

CUTS, SCRAPES & BURNS

PREVENTS infection

RELIEVES
pain quickly

CONTAINS
ALOE & VITAMIN E

Safe for children 2 years and older

NET WT
2.75 oz (78 g)


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