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

Description

Drug Facts

Uses

for temporary relief of pain and itching associated with

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

For external use only

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

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
Questions?

1-800-345-0032

Mon - Fri 8AM- 5PM EST

Dermoplast.com

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.

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

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

Uses

for temporary relief of pain and itching associated with

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

For external use only

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

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
Questions?

1-800-345-0032

Mon - Fri 8AM- 5PM EST

Dermoplast.com

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.

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

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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