dermoplast ®

dermoplast ®
SPL v6
SPL
SPL Set ID 2347f0b8-d463-422d-8583-65624d9a1a91
Route
topical
Published
Effective Date 2021-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzocaine (200 mg) levomenthol (5 mg)
Inactive Ingredients
peg-8 laurate polysorbate 85 methylparaben aloe vera leaf acetylated lanolin alcohols cetyl acetate butane 1,1-difluoroethane

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2014-01-01 Until 2023-12-31

Description

Drug Facts


Medication Information

Warnings

For external use only

Flammabledo not use near heat, flame, or fire or while smoking

Uses

for temporary relief of pain and itching associated with

  • sunburn
  • insect bites
  • minor cuts
  • scrapes
  • minor burns
  • minor skin irritations
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

Description

Drug Facts

Questions?

1-800-345-0032

Mon - Fri 8AM- 5PM EST

Dermoplast.com

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 55105-1
Active ingredients Purpose
Benzocaine 20% Topical analgesic
Menthol 0.5% Topical analgesic
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
Principal Display Panel 78 G Can Label

Dermoplast ®

Pain Relieving Spray

HOSPITAL STRENGTH

PAIN, BURN

& ITCH

RELIEVES PAIN FROM:

Minor Cuts & Scrapes, Burns,

Sunburns and Bug Bites

Fast Itch & Burn Relief

Provides Fast

Pain Relief

Cools and

Comforts

Soothing Aloe

& Lanolin

NET WT. 2.75 oz (78 g)


Structured Label Content

Warnings

For external use only

Flammabledo not use near heat, flame, or fire or while smoking

Uses

for temporary relief of pain and itching associated with

  • sunburn
  • insect bites
  • minor cuts
  • scrapes
  • minor burns
  • minor skin irritations
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 (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 (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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 55105-1 (55105-1)
Active ingredients Purpose
Benzocaine 20% Topical analgesic
Menthol 0.5% Topical analgesic
Allergy Alert (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 (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 (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
Principal Display Panel 78 G Can Label (PRINCIPAL DISPLAY PANEL - 78 g Can Label)

Dermoplast ®

Pain Relieving Spray

HOSPITAL STRENGTH

PAIN, BURN

& ITCH

RELIEVES PAIN FROM:

Minor Cuts & Scrapes, Burns,

Sunburns and Bug Bites

Fast Itch & Burn Relief

Provides Fast

Pain Relief

Cools and

Comforts

Soothing Aloe

& Lanolin

NET WT. 2.75 oz (78 g)


Advanced Ingredient Data


Raw Label Data

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