Dermoplast Anesthetic Pain and Itch Spray

Dermoplast Anesthetic Pain and Itch by

Drug Labeling and Warnings

Dermoplast Anesthetic Pain and Itch by is a Otc medication manufactured, distributed, or labeled by American Spraytech, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DERMOPLAST ANESTHETIC PAIN AND ITCH- benzocaine, menthol 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 Anesthetic Pain and Itch Spray

Drug Facts

Active ingredients

Benzocaine 20%

Menthol 0.5%

Purpose

Topical analgesic

Uses

for temporary relief of pain and itching associted 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 of fatal 
  • do not puncture or incinerate. Conternts 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 informations

  • avoid contact with leather, fabric and unholstery 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, methylaparaben, PEG-400 monolaurate, polysorbate 85

Questions?

1-800-345-0032 

Mon - Fri 8AM - 5PM EST Dermoplast.com

Package Labeling:

Label

DERMOPLAST ANESTHETIC PAIN AND ITCH 
benzocaine, menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68754-680
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTANE (UNII: 6LV4FOR43R)  
CETYL ACETATE (UNII: 4Q43814HXS)  
1,1-DIFLUOROETHANE (UNII: 0B1U8K2ME0)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 85 (UNII: A7F3N56197)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68754-680-0256 g in 1 CAN; Type 0: Not a Combination Product01/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2014
Labeler - American Spraytech, LLC (137135237)

Revised: 1/2020
Document Id: 9b0277b1-b584-b2db-e053-2995a90aa194
Set id: 9b0277b1-b583-b2db-e053-2995a90aa194
Version: 1
Effective Time: 20200102