Dermoplast Pain Relieving: Package Insert and Label Information

DERMOPLAST PAIN RELIEVING- benzocaine and menthol 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
SPRAY

Drug Facts

Active ingredients

Benzocaine USP 20%

Menthol USP 0.5%

Purpose

Topical analgesic
Topical analgesic

Uses

For temporary relief of pain and itching associated with

Warnings

For external use only.
Avoid contact with eyes, mouth and mucous membranes.
Contents flammable. Keep away from fire, open flame and heat.
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 use

  • excessive amounts of this product on broken, blistered, abraded skin or open wounds
  • excessive amounts of this product over large areas of the body
  • this product while smoking
  • store at temperatures above 120 F

When using this product:

  • 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

  • use only as directed

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

Adults and children 2 years and older Apply to affected area not more than 3 to 4 times
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

acetylated lanolin alcohol, aloe barbadensis leaf juice, butane, cetyl acetate, hydrofluorocarbon 152a, methylparaben USP, PEG-400 monolaurate, polysorbate 85

Questions?

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

©2012 Distributed by Medtech Products Inc.

Tarrytown, NY 10591, a Prestige Brands Company

DOT 2P M5702 DP014502

UPC:

3-75137- 85 520 - 6

PRINCIPAL DISPLAY PANEL

Dermoplast

Pain Relieving

Spray

Burn & Itch

Dermoplast Pain Relieving Spray Burn & Itch Net Wt 2.75 oz (78g)
(click image for full-size original)
DERMOPLAST PAIN RELIEVING benzocaine and menthol spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63029-850
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 20 g
MENTHOL (MENTHOL) MENTHOL 0.5 g
Inactive Ingredients
Ingredient Name Strength
ACETYLATED LANOLIN ALCOHOLS
ALOE VERA LEAF
BUTANE
CETYL ACETATE
METHYLPARABEN
POLYETHYLENE GLYCOL 400
POLYSORBATE 85
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63029-850-01 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 01/01/2014
Labeler — Medtech Products Inc. (122715688)

Revised: 05/2014 Medtech Products Inc.

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