SPL v1
SPL
SPL Set ID 4710c90b-ce88-b0b8-e063-6294a90a3860
Route
TOPICAL
Published
Effective Date 2025-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (0.6 g) Benzocaine (0.06 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-28

Description

Benzocaine 6.0% w/w Isopropyl Alcohol 60% w/w


Medication Information

Warnings and Precautions

For external use only.

Caution Flammable.

Stop Use if irritation, redness or other symptoms develop. Consult a doctor if the condition persists or get worse.

Indications and Usage

Directions

Apply to affected area 3-4 times daily for adults and children 2 years of age and older.

Children under 2 years consult physician.

Dosage and Administration

Apply topically as needed to cleanse intendend area;

Apply the product to the skin, take the injection or puncture site as the center, slowly rotate from the insideto the outside, and gradually apply the product for two times, the disinfection area should be more than5cmx5cm, and the action time should be 1min.

Description

For temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

For external use only.

Section 50565-1

Keep out of reach of children

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

Section 50570-1

Do not Use in the eyes.

If contact occurs, rinse thoroughtly with water.

Section 51727-6

Purified water

Section 51945-4

Section 55105-1

Topical Anesthetic

Antiseptic

Section 55106-9

Benzocaine 6.0% w/w

Isopropyl Alcohol 60% w/w


Structured Label Content

Indications and Usage (34067-9)

Directions

Apply to affected area 3-4 times daily for adults and children 2 years of age and older.

Children under 2 years consult physician.

Dosage and Administration (34068-7)

Apply topically as needed to cleanse intendend area;

Apply the product to the skin, take the injection or puncture site as the center, slowly rotate from the insideto the outside, and gradually apply the product for two times, the disinfection area should be more than5cmx5cm, and the action time should be 1min.

Warnings and Precautions (34071-1)

For external use only.

Caution Flammable.

Stop Use if irritation, redness or other symptoms develop. Consult a doctor if the condition persists or get worse.

Description (34089-3)

For temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

For external use only.

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 50570-1 (50570-1)

Do not Use in the eyes.

If contact occurs, rinse thoroughtly with water.

Section 51727-6 (51727-6)

Purified water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Anesthetic

Antiseptic

Section 55106-9 (55106-9)

Benzocaine 6.0% w/w

Isopropyl Alcohol 60% w/w


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)