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.

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Dermoplast

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:
3-75137-85520-6

PRINCIPAL DISPLAY PANEL

Dermoplast
Pain Relieving
Spray
Burn & Itch
Net Wt 2.75 oz (78g)

DERMOPLAST PAIN RELIEVING
benzocaine and menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63029-850
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.5 g

Ingredient Name	Strength
Inactive Ingredients
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTANE (UNII: 6LV4FOR43R)
CETYL ACETATE (UNII: 4Q43814HXS)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYSORBATE 85 (UNII: A7F3N56197)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63029-850-01	75 in 1 CANISTER; Type 0: Not a Combination Product	01/01/2014	08/31/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	01/01/2014	08/31/2017

Labeler - Medtech Products Inc. (122715688)

Revised: 5/2014

Document Id: 1929e4be-3c97-4ecc-ad27-8462971189a3

Set id: 0648c46c-a3db-4b82-971b-50a46098ac7e

Version: 4

Effective Time: 20140508

Medtech Products Inc.