FDA.reportPublic FDA data

Dermoplast ® Kids First Aid Spray

Manufacturer
Advantice Health, LLC.
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:43:05

Label at a glance#

ProductDermoplast Kids First Aid
Active ingredientBENZETHONIUM CHLORIDE, BENZOCAINE
Label structure10 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

avoid contact with leather, fabric and upholstery to prevent possible staining or discoloration store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients(To Deliver) Purpose
Benzethonium chloride 0.2%First aid antiseptic
Benzocaine 15%Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

SPL UNCLASSIFIED SECTION

Flammabledo not use near heat, flame, or fire or while smoking

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • in the eyes
  • over large areas of the body

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or symptoms persist for more than 7 days.
  • symptoms clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
Adults and children 2 years of age and olderapply a small amount to affected area 1 to 3 times daily
Children under 2 years of ageconsult 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

STORAGE AND HANDLING SECTION

  • avoid contact with leather, fabric and upholstery to prevent possible staining or discoloration
  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

PRINCIPAL DISPLAY PANEL - 57 g Can Label
PRINCIPAL DISPLAY PANEL - 57 g Can Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2609039benzethonium chloride 0.2 % / benzocaine 15 % Topical SprayPSN3
2627727Dermoplast Antiseptic Kids 0.2 % / 15 % Topical SprayPSN3
2627727benzethonium chloride 2 MG/ML / benzocaine 150 MG/ML Topical Spray [Dermoplast Antibacterial]SBD3
2609039benzethonium chloride 2 MG/ML / benzocaine 150 MG/ML Topical SpraySCD3
2609039benzethonium chloride 0.2 % / benzocaine 15 % Topical SpraySY3
2627727Dermoplast Antibacterial Kids (benzethonium chloride 0.2 % / benzocaine 15 % ) Topical SpraySY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16864-660-01Dermoplast KidsFirst Aid57 g in 1 CANSPRAY573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16864-660DERMOPLAST KIDS FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) SPRAY [ADVANTICE HEALTH, LLC.]3Current NDC, 1 package rows20241215_29a18018-5214-4080-ac40-e646319e95ce.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
16864-66016864-660-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 400B697894SGQIACT
METHYLAL7H1M4G2NUEIACT
ALOE VERA LEAFZY81Z83H0XIACT
DIMETHYL ETHERAM13FS69BXIACT
BENZETHONIUM CHLORIDEPH41D05744ACTIB
BENZOCAINEU3RSY48JW5ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermoplast Kids First AidBENZETHONIUM CHLORIDE AND BENZOCAINEAdvantice Health, LLC.29a18018-5214-4080-ac40-e646319e95ce2024-12-12WarningsExact identifier
ndc (package): 16864-660-01
ndc (product): 16864-660
ndc11 (package): 16864066001
spl id: 29144767-5d80-020f-e063-6394a90a9deb
spl set id: 29a18018-5214-4080-ac40-e646319e95ce

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.