DERMOPLAST KIDS FIRST AID- benzethonium chloride and benzocaine spray

Dermoplast Kids by

Drug Labeling and Warnings

Dermoplast Kids 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 (To Deliver)	Purpose
Benzethonium chloride 0.2%	First aid antiseptic
Benzocaine 15%	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

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 barbadensis leaf juice, dimethyl ether, methylal, PEG-8

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 - 57 g Can Label

Dermoplast®
KIDS

Antiseptic & Pain
Relieving Spray

FIRST AID
ANTIBACTERIAL & PAIN
RELIEVING SPRAY

STING FREE FORMULA

KILLS 99% OF GERMS
To Help Prevent Infection†

For Minor Cuts, Scrapes & Burns

Disinfects Minor
Burns & Wounds

#1
Doctor
Recommended
Brand*

Provides Fast
Pain Relief

NET WT. 2 oz (57 g)

INGREDIENTS AND APPEARANCE

DERMOPLAST KIDS   FIRST AID
benzethonium chloride and benzocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16864-660
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	150 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
METHYLAL (UNII: 7H1M4G2NUE)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIMETHYL ETHER (UNII: AM13FS69BX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16864-660-01	57 g in 1 CAN; Type 0: Not a Combination Product	03/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/01/2022

Labeler - Advantice Health, LLC. (192527062)