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SPL v1

SPL

SPL Set ID 181e5fa0-ddda-4783-a0b5-ff95bfce6b36

Route

TOPICAL

Published

Effective Date 2017-10-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Chlorhexidine (0.1 g) Benzethonium (0.08 g)

Inactive Ingredients

Glycerin Polyaminopropyl Biguanide Water Methylisothiazolinone

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2017-10-09

Description

DRUG FACTS

Purpose

Cleaning

Medication Information

Warnings and Precautions

For external use only.

Purpose

Cleaning

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 sonsult a doctor if skin irritation develops.
Store in a cool place.

Section 51945-4

Directions

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

Active Ingredient

Benzethonium Chloride .......... 0.08

Chlorhexidine Digluconate ........ 0.10

Inactive Ingredients:

5-chloro-2-methyl-2H-isothiazol-3-one, Methylisothiazolinone, Polyaminopropyl Biguanide, Glycerol, Water

Keep Out of Reach of Children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Structured Label Content

Uses:

Cleans and refreshes hands and face without soap and water

Warnings and Precautions (34071-1)

For external use only.

Section 42229-5 (42229-5)

DRUG FACTS

Section 50570-1 (50570-1)

for external use on hands only.
Stop use and sonsult a doctor if skin irritation develops.
Store in a cool place.

Section 51945-4 (51945-4)

Purpose

Cleaning

Directions

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

Active Ingredient

Benzethonium Chloride .......... 0.08

Chlorhexidine Digluconate ........ 0.10

Inactive Ingredients:

5-chloro-2-methyl-2H-isothiazol-3-one, Methylisothiazolinone, Polyaminopropyl Biguanide, Glycerol, Water

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Advanced Ingredient Data

[{"name": "CHLORHEXIDINE", "unii": "R4KO0DY52L", "classCode": "ACTIB", "strengthNumerator": "0.1", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "BENZETHONIUM", "unii": "1VU15B70BP", "classCode": "ACTIB", "strengthNumerator": "0.08", "strengthDenominator": "1", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYAMINOPROPYL BIGUANIDE", "unii": "322U039GMF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Methylisothiazolinone", "unii": "229D0E1QFA", "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": "For external use only.", "42229-5": "DRUG FACTS", "50570-1": "for external use on hands only. Stop use and sonsult a doctor if skin irritation develops. Store in a cool place.", "Purpose": "Cleaning", "Directions": "Self-dries in seconds. Leaves skin soft and smooth.", "Active Ingredient": "Benzethonium Chloride .......... 0.08 Chlorhexidine Digluconate ........ 0.10", "Inactive Ingredients:": "5-chloro-2-methyl-2H-isothiazol-3-one, Methylisothiazolinone, Polyaminopropyl Biguanide, Glycerol, Water", "Keep out of reach of children.": "In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:25.479672 · Updated: 2026-03-14T22:54:52.931560