a42cf701-83c0-f562-e053-2995a90aad83

SPL v11

SPL

SPL Set ID a42cf701-83c0-f562-e053-2995a90aad83

Route

topical

Published

Effective Date 2020-10-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

benzalkonium (0.2 g)

Inactive Ingredients

polyaminopropyl biguanide glycerin propylene glycol water green tea leaf phenoxyethanol iodopropynyl butylcarbamate

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2020-05-01

Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.2%

Medication Information

Warnings

For external use only. Keep out of eyes.

In case of eye contact, rinse eyes with water.

Stop use and ask a doctor if redness or irritation develops.

Keep out of sunlight.

Purpose

Antimicrobial

Directions

Peel back flap on front to pull out a towelette. Reseal the flap. No need ro rinse.

Inactive Ingredients

Water，Glycerin，Propylene Glycol，Polyaminopropyl Biguanide，Phenoxyethanol ，Iodopropynyl Butylcarbamate，Green Tea Extract.

Description

Benzalkonium Chloride 0.2%

Use

Kills 99.99% of germs.

Section 50565-1

Keep out of reach of children.

Active Ingredient(s)

Benzalkonium Chloride 0.2%

400 Pail Label Principal Display Panel

NDC:76635-001-06

NDC:76635-001-07

NDC:76635-001-09

1 Package Label Principal Display Panel

10 Package Label Principal Display Panel

20 Package Label Principal Display Panel

40 Package Label Principal Display Panel

70 Package Label Principal Display Panel

80 Package Label Principal Display Panel

100 Package Label Principal Display Panel

100 Pail Package Label Principal Display Panel

NDC:76635-001-12

250 Pail Package Label Principal Display Panel

NDC:76635-001-11

Structured Label Content

Warnings

For external use only. Keep out of eyes.

In case of eye contact, rinse eyes with water.

Stop use and ask a doctor if redness or irritation develops.

Keep out of sunlight.

Purpose

Antimicrobial

Directions

Peel back flap on front to pull out a towelette. Reseal the flap. No need ro rinse.

Inactive Ingredients (Inactive ingredients)

Water，Glycerin，Propylene Glycol，Polyaminopropyl Biguanide，Phenoxyethanol ，Iodopropynyl Butylcarbamate，Green Tea Extract.

Use

Kills 99.99% of germs.

Section 50565-1 (50565-1)

Keep out of reach of children.

Active Ingredient(s)

Benzalkonium Chloride 0.2%

400 Pail Label Principal Display Panel (400 Pail Label - Principal Display Panel)

NDC:76635-001-06

NDC:76635-001-07

NDC:76635-001-09

1 Package Label Principal Display Panel (1 Package Label - Principal Display Panel)

10 Package Label Principal Display Panel (10 Package Label - Principal Display Panel)

20 Package Label Principal Display Panel (20 Package Label - Principal Display Panel)

40 Package Label Principal Display Panel (40 Package Label - Principal Display Panel)

70 Package Label Principal Display Panel (70 Package Label - Principal Display Panel)

80 Package Label Principal Display Panel (80 Package Label - Principal Display Panel)

100 Package Label Principal Display Panel (100 Package Label - Principal Display Panel)

100 Pail Package Label Principal Display Panel (100 Pail Package Label - Principal Display Panel)

NDC:76635-001-12

250 Pail Package Label Principal Display Panel (250 Pail Package Label - Principal Display Panel)

NDC:76635-001-11

Advanced Ingredient Data

[{"name": "POLYAMINOPROPYL BIGUANIDE", "unii": "DT9D8Z79ET", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "GREEN TEA LEAF", "unii": "W2ZU1RY8B0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IODOPROPYNYL BUTYLCARBAMATE", "unii": "603P14DHEB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Kills 99.99% of germs.", "50565-1": "Keep out of reach of children.", "Purpose": "Antimicrobial", "Warnings": "For external use only. Keep out of eyes. In case of eye contact, rinse eyes with water. Stop use and ask a doctor if redness or irritation develops. Keep out of sunlight.", "Directions": "Peel back flap on front to pull out a towelette. Reseal the flap. No need ro rinse.", "Active Ingredient(s)": "Benzalkonium Chloride 0.2%", "Inactive ingredients": "Water，Glycerin，Propylene Glycol，Polyaminopropyl Biguanide，Phenoxyethanol ，Iodopropynyl Butylcarbamate，Green Tea Extract.", "400 Pail Label - Principal Display Panel": "NDC:76635-001-06 NDC:76635-001-07 NDC:76635-001-09", "100 Pail Package Label - Principal Display Panel": "NDC:76635-001-12", "250 Pail Package Label - Principal Display Panel": "NDC:76635-001-11"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:23.618969 · Updated: 2026-03-14T23:01:53.224533