Dermoplast Pain Relieving Spray

Dermoplast Pain Relieving Spray
SPL v2
SPL
SPL Set ID dad00c95-4e11-3eec-e053-2a95a90a7a18
Route
TOPICAL
Published
Effective Date 2022-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (200 mg) Menthol (5 mg)
Inactive Ingredients
Aloe Vera Leaf Butane Cetyl Acetate 1,1-difluoroethane Methylparaben Polysorbate 85

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-18

Description

Benzocaine 20% Menthol 0.5%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Benzocaine 20% Menthol 0.5%

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

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:

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?

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

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

Active Ingredients

Benzocaine 20%

Menthol 0.5%

Inactive Ingredients

acetylated lanoline 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 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.


Structured Label Content

Uses

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

Purpose

Topical analgesic

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:

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?

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

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)
Package Labeling:

Active Ingredients (Active ingredients)

Benzocaine 20%

Menthol 0.5%

Inactive Ingredients (Inactive ingredients)

acetylated lanoline 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 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 (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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)