Sanitizing Hand Wipes

SPL v1

SPL

SPL Set ID afb63caa-51d9-17ab-e053-2a95a90a1c0c

Route

TOPICAL

Published

Effective Date 2021-01-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (1.3 mg)

Inactive Ingredients

Aloe Vera Leaf Alpha-tocopherol Acetate Water Glycerin Sodium Benzoate Phenoxyethanol Polysorbate 20 Chamomile Citric Acid Acetate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2021-01-22

Description

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.13%

Use

Sanitizing wipes to help reduce bacteria on skin

Warnings

For external use only.

Directions

For use apply thoroughly to hands as desired. Allow to dry without wiping. Discard wipe in trash receptacle after use. Do not flush.
Pull put wipe from center of roll, next sheet pops up automatically, close lid to retain moisture.

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients

Water (Aqua), Glycerin, Polysorbate 20, Aloe Leaf Extract, Chamomilla Flower Extract, Sodium Benzoate, Phenoxethanol, Tocopheryl Acetate, Citric Acid

When Using This Product

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

Stop Use and Ask A Doctor

Stop use and ask a doctor if irritation develops and persists for more than 72 hours.

Keep Out of Reach of Children

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

Package Label Principal Display Panel

20 CLOTH IN 1 PACKAGE NDC: 78936-023-01

160 CLOTH IN 1 CANISTER NDC: 78936-023-02

Structured Label Content

Use

Sanitizing wipes to help reduce bacteria on skin

Purpose

Antimicrobial

Warnings

For external use only.

Directions

For use apply thoroughly to hands as desired. Allow to dry without wiping. Discard wipe in trash receptacle after use. Do not flush.
Pull put wipe from center of roll, next sheet pops up automatically, close lid to retain moisture.

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Glycerin, Polysorbate 20, Aloe Leaf Extract, Chamomilla Flower Extract, Sodium Benzoate, Phenoxethanol, Tocopheryl Acetate, Citric Acid

When Using This Product (When using this product)

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

Stop Use and Ask A Doctor (Stop use and ask a doctor)

Stop use and ask a doctor if irritation develops and persists for more than 72 hours.

Keep Out of Reach of Children (Keep out of reach of children)

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

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

20 CLOTH IN 1 PACKAGE NDC: 78936-023-01

160 CLOTH IN 1 CANISTER NDC: 78936-023-02

Advanced Ingredient Data

[{"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALPHA-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHAMOMILE", "unii": "FGL3685T2X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID ACETATE", "unii": "DSO12WL7AU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "1.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Use": "Sanitizing wipes to help reduce bacteria on skin", "Purpose": "Antimicrobial", "Warnings": "For external use only.", "Directions": "For use apply thoroughly to hands as desired. Allow to dry without wiping. Discard wipe in trash receptacle after use. Do not flush. Pull put wipe from center of roll, next sheet pops up automatically, close lid to retain moisture.", "Active Ingredient(s)": "Benzalkonium Chloride 0.13%", "Inactive ingredients": "Water (Aqua), Glycerin, Polysorbate 20, Aloe Leaf Extract, Chamomilla Flower Extract, Sodium Benzoate, Phenoxethanol, Tocopheryl Acetate, Citric Acid", "When using this product": "Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water", "Stop use and ask a doctor": "Stop use and ask a doctor if irritation develops and persists for more than 72 hours.", "Keep out of reach of children": "Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "Package Label - Principal Display Panel": "20 CLOTH IN 1 PACKAGE NDC: 78936-023-01 160 CLOTH IN 1 CANISTER NDC: 78936-023-02"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:19.170636 · Updated: 2026-03-14T22:59:14.967734