Dermoplast Anesthetic Pain and Itch: Package Insert and Label Information

DERMOPLAST ANESTHETIC PAIN AND ITCH- benzocaine and menthol, unspecified form 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.

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
(click image for full-size original)

DERMOPLAST ANESTHETIC PAIN AND ITCH
benzocaine, menthol spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68754-680
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 200 mg in 1 g
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM 5 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ACETYLATED LANOLIN ALCOHOLS
ALOE VERA LEAF
BUTANE
CETYL ACETATE
1,1-DIFLUOROETHANE
METHYLPARABEN
POLYSORBATE 85
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68754-680-02 56 g in 1 CAN None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 01/01/2014
Labeler — American Spraytech, LLC (137135237)

Revised: 01/2020 American Spraytech, LLC

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