DERMOPLAST PAIN RELIEVING ANTIBACTERIAL benzethonium chloride and benzocaine spray

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Benzethonium Chloride USP0.2%, BenzocaineUSP 20%
Available from:
Medtech Products Inc.
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final

DERMOPLAST PAIN RELIEVING ANTIBACTERIAL- benzethonium chloride and

benzocaine 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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Dermoplas t

Dermoplas t

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 120 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

®

º

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 AID

Net Wt 2.75 oz (78g)

DERMOPLAST PAIN RELIEVING ANTIBACTERIAL

benzethonium chloride and benzocaine spray

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 30 29 -8 57

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BENZO CAINE (UNII: U3RSY48 JW5) (BENZOCAINE - UNII:U3RSY48 JW5)

BENZOCAINE

0 .2 g

BENZETHO NIUM CHLO RIDE (UNII: PH41D0 5744) (BENZETHONIUM - UNII:1VU15B70 BP)

BENZETHONIUM CHLORIDE 20 g

Inactive Ingredients

Medtech Products Inc.

Ingredient Name

Stre ng th

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

CYCLO METHICO NE (UNII: NMQ3479 9 4Z)

DIPRO PYLENE GLYCO L (UNII: E10 7L8 5C40 )

ISO BUTANE (UNII: BXR49 TP6 11)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

Product Characteristics

Color

WHITE

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 30 29 -8 57-0 1

75 in 1 CANISTER

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH NOT FINAL part348

0 1/0 1/20 10

Labeler -

Medtech Products Inc. (122715688)

Revised: 5/2014

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