ae737cf3-ff74-0b8f-e053-2a95a90a33ed

SPL v2
SPL
SPL Set ID ae737cf3-ff74-0b8f-e053-2a95a90a33ed
Route
topical
Published
Effective Date 2020-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
benzocaine (6 g) isopropyl alcohol (60 g)
Inactive Ingredients
water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-09-04

Purpose

Antiseptic

Description

Benzocaine 6% w/v Isopropyl alcohol 60% w/v


Medication Information

Warnings

For external use only.

Do not use in the eyses.If contact occurs, rinse thoroughly with water.

Stop use if irritation,redness or other symptoms develop.

Consult a doctor if the condition persists or get worse.

CAUTION:Flammable.

Uses

First aid to help prevent infection nearly minor cuts,scrapes and burns.

Purpose

Antiseptic

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.

Inactive Ingredients

Purified water.

Description

Benzocaine 6% w/v Isopropyl alcohol 60% w/v

Principal Display Panel

Active Ingredient

Benzocaine 6% w/v

Isopropyl alcohol 60% w/v

Keep Out of Reach of Children.

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


Structured Label Content

Warnings

For external use only.

Do not use in the eyses.If contact occurs, rinse thoroughly with water.

Stop use if irritation,redness or other symptoms develop.

Consult a doctor if the condition persists or get worse.

CAUTION:Flammable.

Uses

First aid to help prevent infection nearly minor cuts,scrapes and burns.

Purpose

Antiseptic

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.

Inactive Ingredients (Inactive ingredients)

Purified water.

Principal Display Panel (Principal display panel)

Active Ingredient (Active ingredient)

Benzocaine 6% w/v

Isopropyl alcohol 60% w/v

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

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