DERMOPLAST FIRST AID- benzethonium chloride, benzocaine spray 
American Spraytech, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dermoplast First Aid

Drug Facts

Active ingredient

Benzethonium chloride 0.2%

Benzocaine 20%

Purpose

First aid antiseptic

Topical analgesic

Uses

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

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

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

Keep out of reach of children.

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

Directions

  • clean the affected area
Adult and children 2 years of age and older   apply 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 unpholstery 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

Package Labeling:

Label6

DERMOPLAST FIRST AID 
benzethonium chloride, benzocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68754-210
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE2 mg  in 1 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ISOBUTANE (UNII: BXR49TP611)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68754-210-0078 g in 1 BOX; Type 0: Not a Combination Product12/27/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/26/2017
Labeler - American Spraytech, LLC (137135237)

Revised: 12/2017
Document Id: 61578766-8d69-ea53-e053-2991aa0a9919
Set id: 19b81841-22a2-4bb6-9907-e90c346736c1
Version: 1
Effective Time: 20171227
 
American Spraytech, LLC