DERMOPLAST ANESTHETIC PAIN RELIEVING ANTIBACTERIAL- benzocaine, menthol 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.

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Dermoplast Anesthetic Pain Relieving Antibacterial

Drug Facts

Active ingredient

Benzocaine 20%

Menthol 0.5%

Purpose

Topical analgesic

Uses

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.

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 or fatal
do not puncture or incinerate. Contents 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


Adult 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 information

avoid contact with leather, fabric and unpholstery 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, methylparaben, PEG-400 monolaurate, polysorbate 85

Questions?

1-800-345-0032 Mon - Fri 8AM - 5PM EST Dermoplast.com

Package Labeling:

Label5

DERMOPLAST ANESTHETIC PAIN RELIEVING ANTIBACTERIAL
benzocaine, menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68754-209
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTANE (UNII: 6LV4FOR43R)
CETYL ACETATE (UNII: 4Q43814HXS)
1,1-DIFLUOROETHANE (UNII: 0B1U8K2ME0)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYSORBATE 85 (UNII: A7F3N56197)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68754-209-00	78 g in 1 BOX; Type 0: Not a Combination Product	12/27/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	12/26/2017

Labeler - American Spraytech, LLC (137135237)

Revised: 12/2017

Document Id: 6157820d-462c-ea51-e053-2991aa0a847b

Set id: b86fb689-ece2-4931-9689-0d386e215254

Version: 1

Effective Time: 20171227

American Spraytech, LLC