Americaine Topical Spray

Americaine Topical Spray
SPL v8
SPL
SPL Set ID 4fd14452-0285-40c4-b835-36935c2056b2
Route
TOPICAL
Published
Effective Date 2025-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (11.4 g)
Inactive Ingredients
Isobutane Polyethylene Glycol 300 Propane

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-07-14

Description

Americaine ®  Benzocaine  Topical Anesthetic Spray Drug Facts

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Americaine ®  Benzocaine  Topical Anesthetic Spray Drug Facts

Uses

temporarily relieves pain and itching associated with:

  • minor cuts

  • scrapes

  • minor burns

  • insect bites
Section 42229-5

Americaine ® 

Benzocaine 


Topical Anesthetic Spray

Drug Facts

Warnings

For external use only

A
llergy Alert

Directions
  • shake can well, hold 6" to 12" from affected area; spray liberally.

  • 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 physician
Questions?

1-800-344-7239

Do Not Use

this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics.

Flammability Warning

Contents under pressure. Do not puncture or incinerate. Flammable mixture; do not use near fire or flame, or expose to heat or temperatures above 49°C (120°F). Use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

Active Ingredient

Benzocaine 20%

Inactive Ingredients

Polyethylene glycol 300 

Propellant: Isobutane, , propane

Store at room temperature 15°– 25°C (59°– 77°F).

When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor If
  • condition worsens, or symptoms persists for more than 7 days

  • symptoms do not get better, or if redness, irritation, swelling, pain or other symptoms occur or increase
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Principal Display Panel 2 Oz Spray Label

Americaine ® 

Benzocaine

Topical Anesthetic Spray

NET WT. 2 OZ (57 G)


Structured Label Content

Uses

temporarily relieves pain and itching associated with:

  • minor cuts

  • scrapes

  • minor burns

  • insect bites
Section 42229-5 (42229-5)

Americaine ® 

Benzocaine 


Topical Anesthetic Spray

Drug Facts

Purpose

Topical Anesthetic

Warnings

For external use only

A
llergy Alert

Directions
  • shake can well, hold 6" to 12" from affected area; spray liberally.

  • 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 physician
Questions?

1-800-344-7239

Do Not Use (do not use)

this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetics.

Flammability Warning

Contents under pressure. Do not puncture or incinerate. Flammable mixture; do not use near fire or flame, or expose to heat or temperatures above 49°C (120°F). Use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

Active Ingredient (Active ingredient)

Benzocaine 20%

Inactive Ingredients (Inactive ingredients)

Polyethylene glycol 300 

Propellant: Isobutane, , propane

Store at room temperature 15°– 25°C (59°– 77°F).

When Using This Product (When using this product)

avoid contact with the eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens, or symptoms persists for more than 7 days

  • symptoms do not get better, or if redness, irritation, swelling, pain or other symptoms occur or increase
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Principal Display Panel 2 Oz Spray Label (PRINCIPAL DISPLAY PANEL - 2 OZ Spray Label)

Americaine ® 

Benzocaine

Topical Anesthetic Spray

NET WT. 2 OZ (57 G)


Advanced Ingredient Data


Raw Label Data

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