43116-036 - DailyMed Details

43116-036

SPL v2

SPL

SPL Set ID 273b3ae2-6dec-31a4-e063-6294a90aca89

Route

TOPICAL

Published

Effective Date 2024-11-19

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Didecyldimonium (0.2 U) Benzethonium (0.05 U)

Inactive Ingredients

Aloe Barbadensis Leaf Polyoxyl 40 Hydrogenated Castor Oil Centella Asiatica Aqua Glycerin Chrysanthellum Indicum Top

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-11-19

Description

Benzethonium Chloride 0.05% Didecyl Dimethyl Ammonium Chloride 0.2%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Benzethonium Chloride 0.05% Didecyl Dimethyl Ammonium Chloride 0.2%

Use

Wet wipes to help reduce bacteria that potentially can cause disease.

Stop Use

Skin irritation and redness lasts.

Warnings

For external use only.

Do not dispose of wipes in flush toilets

Ask Doctor

If there is any discomfort during use, please stop using immediately.

Directions

Apply to hands or skin. No rinising required. Discard after use.

Do Not Use

●On children less than 2 months of age

●On open skin wounds

When Using

Avoid contact with eyes

If in eyes, rinse thoroughly with water

Active Ingredient

Benzethonium Chloride 0.05%

Didecyl Dimethyl Ammonium Chloride 0.2%

Other Information

Inactive Ingredients

Aqua, Glycerin, Ethoxylated Hydrogenated Castor Oil, Aloe Barbadensis Leaf Extract, Herba Centellae,

Chrysanthellum Indicum Extract

Principal Display Panel

Keep Oot of Reach of Children

In case of accidental ingestion, get medical help or contact a poison control center immediately

Structured Label Content

Use

Wet wipes to help reduce bacteria that potentially can cause disease.

Purpose

Antiseptic

Stop Use

Skin irritation and redness lasts.

Warnings

For external use only.

Do not dispose of wipes in flush toilets

Ask Doctor

If there is any discomfort during use, please stop using immediately.

Directions

Apply to hands or skin. No rinising required. Discard after use.

Do Not Use (Do not use)

●On children less than 2 months of age

●On open skin wounds

When Using

Avoid contact with eyes

If in eyes, rinse thoroughly with water

Active Ingredient

Benzethonium Chloride 0.05%

Didecyl Dimethyl Ammonium Chloride 0.2%

Other Information (Other information)

Inactive Ingredients (Inactive ingredients)

Aqua, Glycerin, Ethoxylated Hydrogenated Castor Oil, Aloe Barbadensis Leaf Extract, Herba Centellae,

Chrysanthellum Indicum Extract

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

In case of accidental ingestion, get medical help or contact a poison control center immediately

Advanced Ingredient Data

[{"name": "ALOE BARBADENSIS LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYOXYL 40 HYDROGENATED CASTOR OIL", "unii": "7YC686GQ8F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CENTELLA ASIATICA", "unii": "7M867G6T1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AQUA", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHRYSANTHELLUM INDICUM TOP", "unii": "STJ856D1Z0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIDECYLDIMONIUM", "unii": "Z7F472XQPA", "classCode": "ACTIB", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "U", "strengthDenominatorUnit": "U"}, {"name": "BENZETHONIUM", "unii": "1VU15B70BP", "classCode": "ACTIB", "strengthNumerator": "0.05", "strengthDenominator": "100", "strengthNumeratorUnit": "U", "strengthDenominatorUnit": "U"}]

Raw Label Data

All Sections (JSON)

{"Use": "Wet wipes to help reduce bacteria that potentially can cause disease.", "Purpose": "Antiseptic", "Stop Use": "Skin irritation and redness lasts.", "Warnings": "For external use only. Do not dispose of wipes in flush toilets", "Ask Doctor": "If there is any discomfort during use, please stop using immediately.", "Directions": "Apply to hands or skin. No rinising required. Discard after use.", "Do not use": "●On children less than 2 months of age ●On open skin wounds", "When Using": "Avoid contact with eyes If in eyes, rinse thoroughly with water", "Active Ingredient": "Benzethonium Chloride 0.05% Didecyl Dimethyl Ammonium Chloride 0.2%", "Inactive ingredients": "Aqua, Glycerin, Ethoxylated Hydrogenated Castor Oil, Aloe Barbadensis Leaf Extract, Herba Centellae, Chrysanthellum Indicum Extract", "Keep Oot Of Reach Of Children": "In case of accidental ingestion, get medical help or contact a poison control center immediately"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:08.977656 · Updated: 2026-03-14T23:12:18.638181