85420-003 all in one antibacterial shave body wash, shampoo

SPL v3

SPL

SPL Set ID a7433f39-a8d9-4c78-864d-d7ef193a7daf

Route

topical

Published

Effective Date 2025-06-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

benzethonium (0.1 g)

Inactive Ingredients

cocamidopropyl betaine water sodium lauryl sulfate cocamide dea sodium chloride dmdm hydantoin citric acid

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2025-06-01

Purpose

Antiseptic

Description

Benzethonium Chloride 0.1%

Medication Information

Warnings

For external use only

Keep out of eyes, ears, or mouth. In case of contect flush eyes with water

Purpose

Antiseptic

Directions

As shave gel: Wet skin and squeeze gel onto finger tips. Spread gel evenly on skin and shave
As body wash: Squeeze body wash onto hands or wash cloth. Apply, lather, and rinse
As shampoo: Wet hair, apply shampoo, work up a rich lather and rinse.

Inactive Ingredients

Water, Cocamidepropyl Betain, Sodium Lauyl Sufate, Cocamide Dea, Sodium Chloride, DMDM Hydantoin, Frgrance, Citric Acid

Description

Benzethonium Chloride 0.1%

Use

As shave gel: Smooth skin when do shaving and help reduce bacteria
As body wash: Body cleaning to help reduce bateria
As shampoo: Hair cleaning to help redice baterial

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation and redness develop, or if condition persists for more than 72 hours

Section 51945-4

Active Ingredient

Benzethonium Chloride 0.1%

Structured Label Content

Warnings

For external use only

Keep out of eyes, ears, or mouth. In case of contect flush eyes with water

Purpose

Antiseptic

Directions

As shave gel: Wet skin and squeeze gel onto finger tips. Spread gel evenly on skin and shave
As body wash: Squeeze body wash onto hands or wash cloth. Apply, lather, and rinse
As shampoo: Wet hair, apply shampoo, work up a rich lather and rinse.

Inactive Ingredients (Inactive ingredients)

Water, Cocamidepropyl Betain, Sodium Lauyl Sufate, Cocamide Dea, Sodium Chloride, DMDM Hydantoin, Frgrance, Citric Acid

Use

As shave gel: Smooth skin when do shaving and help reduce bacteria
As body wash: Body cleaning to help reduce bateria
As shampoo: Hair cleaning to help redice baterial

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation and redness develop, or if condition persists for more than 72 hours

Section 51945-4 (51945-4)

Active Ingredient

Benzethonium Chloride 0.1%

Advanced Ingredient Data

[{"name": "COCAMIDOPROPYL BETAINE", "unii": "5OCF3O11KX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCAMIDE DEA", "unii": "92005F972D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DMDM HYDANTOIN", "unii": "BYR0546TOW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZETHONIUM", "unii": "1VU15B70BP", "classCode": "ACTIB", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Use": "As shave gel: Smooth skin when do shaving and help reduce bacteria As body wash: Body cleaning to help reduce bateria As shampoo: Hair cleaning to help redice baterial", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation and redness develop, or if condition persists for more than 72 hours", "Purpose": "Antiseptic", "Warnings": "For external use only Keep out of eyes, ears, or mouth. In case of contect flush eyes with water", "Directions": "As shave gel: Wet skin and squeeze gel onto finger tips. Spread gel evenly on skin and shave As body wash: Squeeze body wash onto hands or wash cloth. Apply, lather, and rinse As shampoo: Wet hair, apply shampoo, work up a rich lather and rinse.", "Active Ingredient": "Benzethonium Chloride 0.1%", "Inactive ingredients": "Water, Cocamidepropyl Betain, Sodium Lauyl Sufate, Cocamide Dea, Sodium Chloride, DMDM Hydantoin, Frgrance, Citric Acid"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:14.467829 · Updated: 2026-03-14T23:10:29.645873