Dermoplast Pain relieving
Dermoplast Pain relieving is an FDA drug label for the active ingredient BENZOCAINE, MENTHOL manufactured by Advantice Health administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231221.
- Generic name
- BENZOCAINE, MENTHOL
- Manufacturer
- Advantice Health
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 16864-690
- Application
- M017
- Label effective
- 20231221
About this product
Dermoplast Pain relieving is an FDA-registered drug product whose active ingredient is BENZOCAINE, MENTHOL. It is labelled by Advantice Health taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 16864-690, application M017, label effective 20231221. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing BENZOCAINE, MENTHOL are most often described in connection with: temporary relief, itching associated, sunburn insect, bites minor, skin irritations. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses for temporary relief of pain and itching associated with • sunburn • insect bites • minor cuts • minor burns • minor skin irritations
Dosage & Administration
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
Warnings
Warnings 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 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.
Recall and safety notices
3 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0329-2023 | Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First aid antiseptic, Benzocaine 20%) Topical analgesic, NET WT. 2.75 oz (78 g), Distributed by Advantice Health, LLC Cedar Knolls, NJ 07927, NDC# 16864-670-01 | Advantice Health, Llc | Class III | Terminated | 20230301 |
| D-1279-2019 | Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%, Net WT 2.75 oz (78g); Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; UPC 8 51409 00722 6 | Advantice Health | Class III | Terminated | 20190508 |
| D-1280-2019 | Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%; full case of 12-2 oz. cans only; Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; Product Code 80-6802; Case UPC 1 03 16864 68002 7. | Advantice Health | Class III | Terminated | 20190508 |
Frequently asked questions
What is Dermoplast Pain relieving used for?
Uses for temporary relief of pain and itching associated with • sunburn • insect bites • minor cuts • minor burns • minor skin irritations
Who makes Dermoplast Pain relieving?
Advantice Health is the labeler of record for Dermoplast Pain relieving.
What form does Dermoplast Pain relieving come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Dermoplast Pain relieving prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has Dermoplast Pain relieving been recalled?
3 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.