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SPL v1

SPL

SPL Set ID eebaa5cc-bbf7-427a-b412-bb54b38dd328

Route

TOPICAL

Published

Effective Date 2020-10-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.13 g)

Inactive Ingredients

Water Glycerin Propylene Glycol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-10-30

Description

DRUG FACTS

Purpose

Antiseptic

Medication Information

Warnings and Precautions

Warnings

Purpose

Antiseptic

Description

DRUG FACTS

Uses:

Clean and refreshes hands without soap and water.

Section 42229-5

DRUG FACTS

Section 50570-1

For external use only. Stop use and consult doctor if skin irritation develops.

Section 51945-4

Directions

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

Other information:

Storage and handling: Store in cool place.

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:

Clean and refreshes hands 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 only. Stop use and consult doctor if skin irritation develops.

Section 51945-4 (51945-4)

Purpose

Antiseptic

Directions

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

Other information:

Storage and handling: Store in cool place.

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": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses:": "Clean and refreshes hands without soap and water.", "34071-1": "Warnings", "42229-5": "DRUG FACTS", "50570-1": "For external use only. Stop use and consult doctor if skin irritation develops.", "Purpose": "Antiseptic", "Directions": "Self-dries in seconds. Leave skin soft and smooth. Other information: Storage and handling: Store in cool place.", "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: 2026-02-15T11:58:58.602667 · Updated: 2026-03-14T22:58:46.689678