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Drug Facts
Distributed by Advantice Health, LLC
Cedar Knolls, NJ 07927
Dermoplast Sunburn And Burn Relief
FDA Label NDC 16864-681
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 Sunburn And Burn Relief (NDC 16864-681). 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, allergy alert, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients | Purpose |
|---|---|
| Benzocaine 20% | Topical analgesic |
| Menthol 0.5% | Topical analgesic |
Uses
for temporary relief of pain and itching associated with
- sunburn
- insect bites
- minor cuts
- scrapes
- 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 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.
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
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
| 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 lanolin 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
Principal Display Panel - 78 G Can Label
Dermoplast®
Pain Relieving Spray
HOSPITAL TRUSTED BRAND
SUNBURN &
BURN RELIEF
RELIEVES PAIN & ITCH
from sunburns, minor burns
& other skin irritations
#1 Doctor Recommended Brand*
Provides Fast
Pain Relief
Menthol Cools
& Comforts
Soothing Aloe
& Lanolin
NET WT. 2.75 oz (78 g)
Principal Display Panel (78 g Can Label)
* Please review the disclaimer below.
