DERMOPLAST SUNBURN AND BURN RELIEF- benzocaine and levomenthol spray

Dermoplast Sunburn and Burn Relief by

Drug Labeling and Warnings

Dermoplast Sunburn and Burn Relief by is a Otc medication manufactured, distributed, or labeled by Advantice Health, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Benzocaine 20%	Topical analgesic
Menthol 0.5%	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

• Adults 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 upholstery 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

SPL UNCLASSIFIED SECTION

Distributed by Advantice Health, LLC
Cedar Knolls, NJ 07927

PRINCIPAL DISPLAY PANEL - 78 g Can Label

Dermoplast®
Pain Relieving Spray

HOSPITAL TRUSTED BRAND

SUNBURN &
BURN RELIEF

RELIEVES PAIN & ITCH
from sunburns, minor burns
& other skin irritations

#1 Doctor Recommended Brand*

Provides Fast
Pain Relief

Menthol Cools
& Comforts

Soothing Aloe
& Lanolin

NET WT. 2.75 oz (78 g)

INGREDIENTS AND APPEARANCE

DERMOPLAST SUNBURN AND BURN RELIEF 
benzocaine and levomenthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16864-681
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PEG-8 LAURATE (UNII: 762O8IWA10)
POLYSORBATE 85 (UNII: A7F3N56197)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ACETYLATED LANOLIN ALCOHOLS (UNII: SNN716810P)
CETYL ACETATE (UNII: 4Q43814HXS)
BUTANE (UNII: 6LV4FOR43R)
1,1-DIFLUOROETHANE (UNII: 0B1U8K2ME0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16864-681-01	78 g in 1 CAN; Type 0: Not a Combination Product	05/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	05/15/2021

Labeler - Advantice Health, LLC (192527062)