DERMOPLAST FIRST AID- benzethonium chloride and benzocaine spray

Dermoplast First Aid by

Drug Labeling and Warnings

Dermoplast First Aid by is a Otc medication manufactured, distributed, or labeled by Moberg Pharma North America LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purposes
Benzethonium chloride 0.2%	First aid antiseptic
Benzocaine 20%	Topical analgesic

Uses

first aid for the temporary relief of pain and itching and to help prevent infection in minor cuts, scrapes and burns

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.

Do not use

• in the eyes
• over large areas of the body

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.

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

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

• clean the affected area

• Adults and children 2 years of age and older: apply a small amount to affected area 1 to 3 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

aloe vera gel (decolorized), cyclomethicone, dipropylene glycol, isobutane, SD alcohol 40-B (73% v/v), tocopheryl acetate (vitamin E acetate)

Questions?

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

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Distributed by Advantice Health, LLC
Cedar Knolls, NJ 07927

PRINCIPAL DISPLAY PANEL - 78 g Can Label

Dermoplast®
Antiseptic & Pain
Relieving Spray

HOSPITAL STRENGTH

FIRST AID
ANTIBACTERIAL SPRAY

KILLS 99% OF GERMS
To Prevent Infection

For Minor Cuts, Scrapes & Burns

Disinfects
Burns &
Wounds

Provides
Fast
Pain Relief

Soothing
Aloe &
Vitamin E

NET WT. 2.75 oz (78 g)

INGREDIENTS AND APPEARANCE

DERMOPLAST FIRST AID 
benzethonium chloride and benzocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16864-670
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	2 mg  in 1 g
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CYCLOMETHICONE (UNII: NMQ347994Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ISOBUTANE (UNII: BXR49TP611)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16864-670-01	78 g in 1 CAN; Type 0: Not a Combination Product	01/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333A	01/01/2010

Labeler - Advantice Health, LLC (192527062)