Dermoplast Kids Spray
FDA Label NDC 16864-660

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advantice Health, Llc. for the product Dermoplast Kids (NDC 16864-660). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, do not use, when using this product, ask a doctor before use if you have, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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.

Distributed by
Advantice Health, LLC
Cedar Knolls, NJ 07927

Otc - Purpose

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

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

Otc - Keep Out Of Reach Of Children

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 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

  • 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

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)

Principal Display Panel (57 g Can Label)

Principal Display Panel (57 g Can Label)

* Please review the disclaimer below.