SPL v1
SPL
SPL Set ID cda09196-1105-4993-ab44-dac2c69c7a24
Route
TOPICAL
Published
Effective Date 2020-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Water Glycerin Ethylhexylglycerin Phenoxyethanol Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-08-19
Description

DRUG FACTS

Purpose

Antiseptic

Medication Information

Warnings and Precautions

Warnings

Purpose

Antiseptic

Description

DRUG FACTS

Uses:

For hand sanitizing to decrease bacteria on the skin.

Recommended for repeated use.

Section 42229-5

DRUG FACTS

Section 50570-1

For external use only. 

When using this product avoid contact with the eyes .In case of contact, flush eyes thoroughly with water .

Stop use and ask a doctor if Irritation and redness develop and persist.

Section 51945-4

Directions

Take wipe from pouch and rub thoroughly over all surfaces of both hands.

Rub hands together briskly to dry.

Dispose of wipe.

Active Ingredient

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

Inactive Ingredients:

Ethylhexylglycerin, Glycerin, Phenoxyethanol, Propylene Glycol, Purified Water

Keep Out of Reach of Children.

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

Structured Label Content

Uses:

For hand sanitizing to decrease bacteria on the skin.

Recommended for repeated use.

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

DRUG FACTS

Section 50570-1 (50570-1)

For external use only. 

When using this product avoid contact with the eyes .In case of contact, flush eyes thoroughly with water .

Stop use and ask a doctor if Irritation and redness develop and persist.

Section 51945-4 (51945-4)

Purpose

Antiseptic

Directions

Take wipe from pouch and rub thoroughly over all surfaces of both hands.

Rub hands together briskly to dry.

Dispose of wipe.

Active Ingredient

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

Inactive Ingredients:

Ethylhexylglycerin, Glycerin, Phenoxyethanol, Propylene Glycol, 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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:30.207963 · Updated: 2026-03-14T22:58:05.187766