a5aafa28-7c3e-0f9d-e053-2995a90a4027

SPL v3

SPL

SPL Set ID a5aafa28-7c3e-0f9d-e053-2995a90a4027

Route

topical

Published

Effective Date 2020-05-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

benzalkonium (0.13 g)

Inactive Ingredients

iodopropynyl butylcarbamate polysorbate 20 glycerin water bronopol aloe vera leaf propylene glycol .alpha.-tocopherol acetate, dl- fragrance lavender & chia f-153480

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2020-05-16

Purpose

Antibacterial

Description

Drug Facts

Medication Information

Warnings

For external use only.

Purpose

Antibacterial

Directions

Open packet,remove and unfold pre-moistened tissue.

Wipe hand including nails and cuticles

Allow to dry without wiping.

Discard properly after use.

Do not flush down toilet.

Other Information

Store at room temperature.

Inactive Ingredients

Aloe barbadensis leaf extract，Aqua，2-Bromo-2-Nitropropane-1,3-Diol，Fragrance，Glycerin，IodopropynylButylcarbamate，Polysorbate 20，Propylene Glycol，Tocopheryl Acetate

Description

Drug Facts

Use

For hand washing to decrease bacteria on the skin.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children except with adult supervision.

Section 50566-9

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

Section 50567-7

When using this product avoid contact with eyes.If contact occurs,rinse eyes thoroughly with water.

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Package Label Principal Display Panel

Structured Label Content

Warnings

For external use only.

Purpose

Antibacterial

Directions

Open packet,remove and unfold pre-moistened tissue.

Wipe hand including nails and cuticles

Allow to dry without wiping.

Discard properly after use.

Do not flush down toilet.

Other Information (Other information)

Store at room temperature.

Inactive Ingredients (Inactive ingredients)

Aloe barbadensis leaf extract，Aqua，2-Bromo-2-Nitropropane-1,3-Diol，Fragrance，Glycerin，IodopropynylButylcarbamate，Polysorbate 20，Propylene Glycol，Tocopheryl Acetate

Use

For hand washing to decrease bacteria on the skin.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children except with adult supervision.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes.If contact occurs,rinse eyes thoroughly with water.

Active Ingredient(s)

Benzalkonium Chloride 0.13%

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

Advanced Ingredient Data

[{"name": "IODOPROPYNYL BUTYLCARBAMATE", "unii": "603P14DHEB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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": "BRONOPOL", "unii": "6PU1E16C9W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE, DL-", "unii": "WR1WPI7EW8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FRAGRANCE LAVENDER & CHIA F-153480", "unii": "SXS9CO2TZK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "For hand washing to decrease bacteria on the skin.", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children except with adult supervision.", "50566-9": "Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.", "50567-7": "When using this product avoid contact with eyes.If contact occurs,rinse eyes thoroughly with water.", "Purpose": "Antibacterial", "Warnings": "For external use only.", "Directions": "Open packet,remove and unfold pre-moistened tissue. Wipe hand including nails and cuticles Allow to dry without wiping. Discard properly after use. Do not flush down toilet.", "Other information": "Store at room temperature.", "Active Ingredient(s)": "Benzalkonium Chloride 0.13%", "Inactive ingredients": "Aloe barbadensis leaf extract，Aqua，2-Bromo-2-Nitropropane-1,3-Diol，Fragrance，Glycerin，IodopropynylButylcarbamate，Polysorbate 20，Propylene Glycol，Tocopheryl Acetate"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:23.622151 · Updated: 2026-03-14T23:01:53.224533