Dermoplast Pain Relieving Spray
FDA Label NDC 16864-690

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 for the product Dermoplast Pain Relieving (NDC 16864-690). 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 active ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Benzocaine 20%

Menthol 0.5%

Purpose

Topical analgesic

Uses

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

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.

When Using This Product

  • 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

  • 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

 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

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

Inactive Ingredients

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

Questions?

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

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