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SPL v1

SPL

SPL Set ID 1da35e36-a616-41cd-8f30-6b74a0b6008f

Route

TOPICAL

Published

Effective Date 2020-06-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.13 g)

Inactive Ingredients

Water Clonitrate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-06-05

Description

DRUG FACTS

Purpose

Antiseptic

Medication Information

Warnings and Precautions

Warnings

Purpose

Antiseptic

Description

DRUG FACTS

Uses:

Cleans and refreshes hands and face without soap and water.

Section 42229-5

DRUG FACTS

Section 50570-1

For external use on hands only. Stop use and ask a doctor if irritation develops.

Store and handling

Store in a cool place.

Section 51945-4

Directions

Self-dries in seconds. Leave skin soft and smooth.

Active Ingredient

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

Inactive Ingredients:

Glycerol,1,2-propanediol, 2-phenoxyetanol, Didecyl dimethyl ammonium chloride, 2-propandiol, Antibacterial synerists, Stabilizer, Water

Keep Out of Reach of Children.

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

Structured Label Content

Uses:

Cleans and refreshes hands and face without soap and water.

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

DRUG FACTS

Section 50570-1 (50570-1)

For external use on hands only. Stop use and ask a doctor if irritation develops.

Store and handling

Store in a cool place.

Section 51945-4 (51945-4)

Purpose

Antiseptic

Directions

Self-dries in seconds. Leave skin soft and smooth.

Active Ingredient

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

Inactive Ingredients:

Glycerol,1,2-propanediol, 2-phenoxyetanol, Didecyl dimethyl ammonium chloride, 2-propandiol, Antibacterial synerists, Stabilizer, 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

[{"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CLONITRATE", "unii": "MIG1YFL8MD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses:": "Cleans and refreshes hands and face without soap and water.", "34071-1": "Warnings", "42229-5": "DRUG FACTS", "50570-1": "For external use on hands only. Stop use and ask a doctor if irritation develops. Store and handling Store in a cool place.", "Purpose": "Antiseptic", "Directions": "Self-dries in seconds. Leave skin soft and smooth.", "Active Ingredient": "Benzalkonium Chloride .......... 0.13 %", "Inactive Ingredients:": "Glycerol,1,2-propanediol, 2-phenoxyetanol, Didecyl dimethyl ammonium chloride, 2-propandiol, Antibacterial synerists, Stabilizer, Water", "Keep out of reach of children.": "if swallowed get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:48.210960 · Updated: 2026-03-14T22:57:05.210150