Dermoplast Pain Relieving Antibacterial: Package Insert and Label Information

DERMOPLAST PAIN RELIEVING ANTIBACTERIAL- benzocaine and benzethonium chloride spray
Medtech Products Inc.

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.

Dermoplast ®
Anesthetic
PAIN RELIEVING
ANTIBACTERIAL
SPRAY

Drug Facts

Active ingredients

Benzethonium Chloride USP 0.2%

Benzocaine USP 20%

Purpose

First Aid Antiseptic
Topical analgesic

Uses

First aid to help prevent skin infection in minor cuts, scrapes, and burns; 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.
Avoid contact with eyes, mouth and mucous membranes.
Contents flammable. Keep away from fire, open flame and heat.
Do not store at temperatures about 120º F. Contents under pressure. Do not puncture or incinerate can.

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:

  • apply over large areas of the body
  • use in case of deep or puncture wounds, animal bites or serious burns unless directed by a doctor
  • use longer than 1 week unless directed by a doctor
  • use this product while smoking

When using this product:

  • use only as directed
  • do not spray in eyes, on the face or in the mouth
  • do not inhale
  • intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal

Stop use and ask a doctor if:

  • condition worsens
  • symptoms persist for more than 7 days or 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 Posion Control Center (1-800-222-1222) right away.

Directions

Clean the affected area

Adults and children 2 years and older

Apply a small amount to affected area 1 to 3 times daily

Children under 2 years of age Consult doctor

To use this product, hold can 6 to 12 inches away from affected area. Direct spray nozzle towards skin and press button to activate spray. To apply to face , first spray into palm of hand then touch hand to face.

Other information

Caution: Avoid contact with leather, fabric and upholstery to prevent possible staining or discoloration.

Inactive ingredients

aloe barbadensis leaf juice, cyclomethicone, dipropylene glycol, isobutane, SD alcohol 40-B, tocopheryl acetate (vitamin E acetate)

Questions?

1-800-443-4908
Mon.-Fri. 8am to 8pm EST Dermoplast.com

©2012 Distributed by Medtech Products Inc.

Tarrytown, NY 10591, a Prestige Brands Company

DOT 2P M5702 DP015503

PRINCIPAL DISPLAY PANEL

Dermoplast
Pain Relieving
ANTIBACTERIAL
Spray
FIRST AIDNet Wt 2.75 oz (78g)

Dermoplast Pain Relieving ANTIBACTERIAL Spray FIRST AID Net Wt 2.75 oz (78g)
(click image for full-size original)
DERMOPLAST PAIN RELIEVING ANTIBACTERIAL benzethonium chloride and benzocaine spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-857
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 0.2 g
BENZETHONIUM CHLORIDE (BENZETHONIUM) BENZETHONIUM CHLORIDE 20 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF
CYCLOMETHICONE
DIPROPYLENE GLYCOL
ISOBUTANE
.ALPHA.-TOCOPHEROL ACETATE
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63029-857-01 75 SPRAY in 1 CANISTER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 01/01/2010
Labeler — Medtech Products Inc. (122715688)

Revised: 05/2014 Medtech Products Inc.

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