Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f6591163-8a63-4f5e-8845-71809e744d5b
Route
TOPICAL
Published
Effective Date 2011-04-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzocaine (180 mg) Tetracaine (20 mg)
Inactive Ingredients
Water Carbomer Homopolymer Type C Glycerin Stearic Acid Sodium Lauryl Sulfate Isopropyl Alcohol Cetyl Alcohol Alcohol Aloe Hyaluronate Sodium Polysorbate 20 Butylene Glycol Castor Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-08-31
Description

Benzocaine 18% (w/w), Tetracaine 2% (w/w), Inactive Ingredients ; water, Isoprpopyl Alcohol, gkycerin, Ethyl alcohol, Staeric Acid, Carbomer, Sodium Hyaluronate, castor oil,Innovatech Inc, Net Wt. 15g

Medication Information

Warnings and Precautions
 Do not use in or near the eyes

•    Do not use in large amount particularly over the raw surfaces or blisters

Stop use and Ask Doctors if

•    Allergic reactions occurs

•    Condition worsen and does not improve

•    Symptoms clean up and returns within few day

•    itching, redness, burning , swelling or other symptoms occurs

•    Keep both used and unused medicine out of the reach of children or pets

•    If swallowed get medical attention right away Call your doctor immediately.
Indications and Usage
Use for reducing pain or discomfort from minor cuts, abrasions, minor burns, sun burns, insect bites, poison ivy, hemorrhoids pain and Itching. Use small amount (1 to 2 gm) of this medication, apply on the skin with gentle massage to numb the skin or relieve pain (do not occlude). Children under 2 years of age, consult your doctor
Dosage and Administration
Use for reducing pain or discomfort from minor cuts, abrasions, minor burns, sun burns, insect bites, poison ivy, hemorrhoids pain and Itching. Use small amount (1 to 2 gm) of this medication, apply on the skin with gentle massage to numb the skin or relieve pain (do not occlude). Children under 2 years of age, consult your doctor
Description

Benzocaine 18% (w/w), Tetracaine 2% (w/w), Inactive Ingredients ; water, Isoprpopyl Alcohol, gkycerin, Ethyl alcohol, Staeric Acid, Carbomer, Sodium Hyaluronate, castor oil,Innovatech Inc, Net Wt. 15g

Section 34084-4
Stop use and Ask Doctors if

•    Allergic reactions occurs

•    Condition worsen and does not improve

•    Symptoms clean up and returns within few day

•    itching, redness, burning , swelling or other symptoms occurs

•    Keep both used and unused medicine out of the reach of children or pets

•    If swallowed get medical attention right away Call your doctor immediately.
Section 50565-1
Keep both used and unused medicine out of the reach of children or pets
Section 50570-1
•    Do not use in or near the eyes

•    Do not use in large amount particularly over the raw surfaces or blisters

Stop use and Ask Doctors if

•    Allergic reactions occurs

•    Condition worsen and does not improve

•    Symptoms clean up and returns within few day

•    itching, redness, burning , swelling or other symptoms occurs

•    Keep both used and unused medicine out of the reach of children or pets

•    If swallowed get medical attention right away Call your doctor immediately.

Section 51727-6
Inactive Ingredients; water, Isoprpopyl Alcohol, glycerin, Ethyl alcohol, Staeric Acid, Carbomer, Sodium Hyaluronate, castor oil, sodium lauryl sulfate,

Section 51945-4
carton.jpg
Section 55105-1
Use for reducing pain or discomfort from minor cuts, abrasions, minor burns, sun burns, insect bites, poison ivy, hemorrhoids pain and Itching. Use small amount (1 to 2 gm) of this medication, apply on the skin with gentle massage to numb the skin or relieve pain (do not occlude). Children under 2 years of age, consult your doctor
Section 55106-9
Benzocaine 18% (w/w), Tetracaine 2% (w/w), Inactive Ingredients; water, Isoprpopyl Alcohol, gkycerin, Ethyl alcohol, Staeric Acid, Carbomer, Sodium Hyaluronate, castor oil,Innovatech Inc, Net Wt. 15g

Structured Label Content

Indications and Usage (34067-9)
Use for reducing pain or discomfort from minor cuts, abrasions, minor burns, sun burns, insect bites, poison ivy, hemorrhoids pain and Itching. Use small amount (1 to 2 gm) of this medication, apply on the skin with gentle massage to numb the skin or relieve pain (do not occlude). Children under 2 years of age, consult your doctor
Dosage and Administration (34068-7)
Use for reducing pain or discomfort from minor cuts, abrasions, minor burns, sun burns, insect bites, poison ivy, hemorrhoids pain and Itching. Use small amount (1 to 2 gm) of this medication, apply on the skin with gentle massage to numb the skin or relieve pain (do not occlude). Children under 2 years of age, consult your doctor
Warnings and Precautions (34071-1)
 Do not use in or near the eyes

•    Do not use in large amount particularly over the raw surfaces or blisters

Stop use and Ask Doctors if

•    Allergic reactions occurs

•    Condition worsen and does not improve

•    Symptoms clean up and returns within few day

•    itching, redness, burning , swelling or other symptoms occurs

•    Keep both used and unused medicine out of the reach of children or pets

•    If swallowed get medical attention right away Call your doctor immediately.
Section 34084-4 (34084-4)
Stop use and Ask Doctors if

•    Allergic reactions occurs

•    Condition worsen and does not improve

•    Symptoms clean up and returns within few day

•    itching, redness, burning , swelling or other symptoms occurs

•    Keep both used and unused medicine out of the reach of children or pets

•    If swallowed get medical attention right away Call your doctor immediately.
Section 50565-1 (50565-1)
Keep both used and unused medicine out of the reach of children or pets
Section 50570-1 (50570-1)
•    Do not use in or near the eyes

•    Do not use in large amount particularly over the raw surfaces or blisters

Stop use and Ask Doctors if

•    Allergic reactions occurs

•    Condition worsen and does not improve

•    Symptoms clean up and returns within few day

•    itching, redness, burning , swelling or other symptoms occurs

•    Keep both used and unused medicine out of the reach of children or pets

•    If swallowed get medical attention right away Call your doctor immediately.

Section 51727-6 (51727-6)
Inactive Ingredients; water, Isoprpopyl Alcohol, glycerin, Ethyl alcohol, Staeric Acid, Carbomer, Sodium Hyaluronate, castor oil, sodium lauryl sulfate,

Section 51945-4 (51945-4)
carton.jpg
Section 55105-1 (55105-1)
Use for reducing pain or discomfort from minor cuts, abrasions, minor burns, sun burns, insect bites, poison ivy, hemorrhoids pain and Itching. Use small amount (1 to 2 gm) of this medication, apply on the skin with gentle massage to numb the skin or relieve pain (do not occlude). Children under 2 years of age, consult your doctor
Section 55106-9 (55106-9)
Benzocaine 18% (w/w), Tetracaine 2% (w/w), Inactive Ingredients; water, Isoprpopyl Alcohol, gkycerin, Ethyl alcohol, Staeric Acid, Carbomer, Sodium Hyaluronate, castor oil,Innovatech Inc, Net Wt. 15g

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:12.883186 · Updated: 2026-03-14T22:52:35.540850