SPL v1
SPL
SPL Set ID 28591a97-9291-48c8-a8e3-c419180331b3
Route
TOPICAL
Published
Effective Date 2023-11-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-15

Description

DRUG FACTS

Purpose

Antiseptic


Medication Information

Warnings and Precautions

Warnings

Purpose

Antiseptic

Description

DRUG FACTS

Uses:

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

Section 42229-5

DRUG FACTS

Section 50570-1

For external use only.

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

Section 51945-4

Directions

Tear open packet,unfold and use as a washcloth.

Other Information:

Store at room temperature.

Active Ingredient

Benzalkonium Chloride .......... 0.13 %

Inactive Ingredients:

Purified Water

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.


Structured Label Content

Uses:

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

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

DRUG FACTS

Section 50570-1 (50570-1)

For external use only.

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

Section 51945-4 (51945-4)

Purpose

Antiseptic

Directions

Tear open packet,unfold and use as a washcloth.

Other Information:

Store at room temperature.

Active Ingredient

Benzalkonium Chloride .......... 0.13 %

Inactive Ingredients:

Purified Water

Keep Out of Reach of Children. (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)