42003-208 - DailyMed Details

42003-208

SPL v2

SPL

SPL Set ID b5741e4f-5c14-859e-e053-2995a90a1aa9

Route

TOPICAL

Published

Effective Date 2020-03-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.13 g)

Inactive Ingredients

Phenoxyethanol Edetate Disodium Anhydrous Citric Acid Monohydrate Aloe Vera Leaf Lemon Water Cetylpyridinium Chloride Chamomile

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Description

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Benzalkonium chloride 0.13%

Use

Decreases bacteria on the skin

Section 50565-1

Keep out of reach o1 children. If swallowed, get medical help or contact Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a sefious condition.

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Warnings

KEEP OUT OF REACH OF CHILDREN . FOR EXTERNAL USE ONLY . KEEP OUT OF EYES AND MOUTH . STOP USE IF YOU FEEL UNWELL OR IRRITATED

Directions

Open package. Pull wipe. Close package to retain moisture

Wet hands thoroughly with product.

Allow to dry without rinsing.

Do Not Use

in childr&n less than 2 months of age

on open skin wounds

Other Information

store between 15-30C (59-86F)

Avoid freezing and exessive heat aboce 40C (104F)

Active Ingredient(s)

Benzalkonium chloride 0.13%

Inactive Ingredients

Cetylpyrdinium chloride, Propylene Glycol, 2-phenoxyethanol, Disodium EDTA., Citric Acid, Fragrance, Aloe Barbadensis Leaf Juice, Water.

Package Label Principal Display Panel

Structured Label Content

Use

Decreases bacteria on the skin

Section 50565-1 (50565-1)

Keep out of reach o1 children. If swallowed, get medical help or contact Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a sefious condition.

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Purpose

Antiseptic

Warnings

KEEP OUT OF REACH OF CHILDREN . FOR EXTERNAL USE ONLY . KEEP OUT OF EYES AND MOUTH . STOP USE IF YOU FEEL UNWELL OR IRRITATED

Directions

Open package. Pull wipe. Close package to retain moisture

Wet hands thoroughly with product.

Allow to dry without rinsing.

Do Not Use (Do not use)

in childr&n less than 2 months of age

on open skin wounds

Other Information (Other information)

store between 15-30C (59-86F)

Avoid freezing and exessive heat aboce 40C (104F)

Active Ingredient(s)

Benzalkonium chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Cetylpyrdinium chloride, Propylene Glycol, 2-phenoxyethanol, Disodium EDTA., Citric Acid, Fragrance, Aloe Barbadensis Leaf Juice, Water.

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Advanced Ingredient Data

[{"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM ANHYDROUS", "unii": "8NLQ36F6MM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LEMON", "unii": "24RS0A988O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "CETYLPYRIDINIUM CHLORIDE", "unii": "D9OM4SK49P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHAMOMILE", "unii": "FGL3685T2X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Decreases bacteria on the skin", "50565-1": "Keep out of reach o1 children. If swallowed, get medical help or contact Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation or rash occurs. These may be signs of a sefious condition.", "50567-7": "When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.", "Purpose": "Antiseptic", "Warnings": "KEEP OUT OF REACH OF CHILDREN . FOR EXTERNAL USE ONLY . KEEP OUT OF EYES AND MOUTH . STOP USE IF YOU FEEL UNWELL OR IRRITATED", "Directions": "Open package. Pull wipe. Close package to retain moisture Wet hands thoroughly with product. Allow to dry without rinsing.", "Do not use": "in childr&n less than 2 months of age on open skin wounds", "Other information": "store between 15-30C (59-86F) Avoid freezing and exessive heat aboce 40C (104F)", "Active Ingredient(s)": "Benzalkonium chloride 0.13%", "Inactive ingredients": "Cetylpyrdinium chloride, Propylene Glycol, 2-phenoxyethanol, Disodium EDTA., Citric Acid, Fragrance, Aloe Barbadensis Leaf Juice, Water."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:07.868574 · Updated: 2026-03-14T23:00:28.895348