FDA.reportPublic FDA data

Dermoplast Pain relieving Spray

Manufacturer
Advantice Health
Effective date
2023-12-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:27

Label at a glance#

ProductDermoplast Pain relieving
Active ingredientBENZOCAINE, MENTHOL
Label structure8 sections

Indications and uses

for temporary relief of pain and itching associated with • sunburn • insect bites • minor cuts • minor burns • minor skin irritations 

Dosage and administration

 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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Menthol 0.5%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

for temporary relief of pain and itching associated with • sunburn • insect bites • minor cuts • minor burns • minor skin irritations 

Warnings

WARNINGS SECTION

For external use only

do not use near heat, flame, or fire or while smoking Flammable 

Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics. Allergy alert:

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes. Do not spray in the face of 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

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

 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

SPL UNCLASSIFIED 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

acetylated lanoline alcohol, aloe vera gel (decolorized), butane, cetyl acetate, hydrofluorocarbon 152a, methylparaben, PEG-400 monolaurate, polysorbate 85

Questions?

OTC - QUESTIONS SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199864benzocaine 20 % / menthol 0.5 % Topical SprayPSN2
763484Dermoplast 20 % / 0.5 % Topical SprayPSN2
763484benzocaine 200 MG/ML / menthol 5 MG/ML Topical Spray [Dermoplast Pain]SBD2
199864benzocaine 200 MG/ML / menthol 5 MG/ML Topical SpraySCD2
199864benzocaine 20 % / menthol 0.5 % Topical SpraySY2
763484Dermoplast Insect Itch and Sting Relief (benzocaine 20 % / menthol 0.5 % ) Topical SpraySY2
763484Dermoplast Pain (benzocaine 20 % / menthol 0.5 % ) Topical SpraySY2

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
16864-690-01Dermoplast Pain relieving78 g in 1 CANSPRAY782

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16864-690DERMOPLAST PAIN RELIEVING (BENZOCAINE, MENTHOL) SPRAY [ADVANTICE HEALTH]2Current NDC, Legacy NDC, 1 package rows20231222_dad00c95-4e11-3eec-e053-2a95a90a7a18.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
16864-69016864-690-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
BUTANE6LV4FOR43RIACT
CETYL ACETATE4Q43814HXSIACT
1,1-DIFLUOROETHANE0B1U8K2ME0IACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 85A7F3N56197IACT
BENZOCAINEU3RSY48JW5ACTIB
MENTHOLL7T10EIP3AACTIB

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 Pain relievingBENZOCAINE, MENTHOLAdvantice Healthdad00c95-4e11-3eec-e053-2a95a90a7a182023-12-21WarningsExact identifier
ndc (package): 16864-690-01
ndc (product): 16864-690
ndc11 (package): 16864069001
spl id: 0d12185e-8d41-7d76-e063-6294a90a2cf4
spl set id: dad00c95-4e11-3eec-e053-2a95a90a7a18

Reported adverse events (FAERS/openFDA)#

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