81244-001 Sanitizing Alcohol Free Wipes

SPL v5

SPL

SPL Set ID b6c6fad3-be59-21d7-e053-2995a90ae596

Route

TOPICAL

Published

Effective Date 2020-12-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.13 g)

Inactive Ingredients

Water Propylene Glycol Polysorbate 20 Disodium Cocoamphodiacetate Citric Acid Monohydrate Edetate Disodium Anhydrous Potassium Sorbate .alpha.-tocopherol Acetate Fragrance Lemon Orc2001060 Aloe Vera Leaf

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-12-20

Description

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Benzalkonium chloride 0.13%

Uses

For hand sanitizing to decrease bacteria on the skin.

Apply topically to the skin to help prevent cross contamination.

Recommended for repeated use.

Dries in seconds.

Section 50565-1

Keep out of the reach of children unless under adult supervision

Section 51945-4

800 CT REFILL, NDC: 81244-001-01

Warnings

For external use only

May irritate eyes

Keep out of the reach of children unless under adult supervision

Directions

Tear V notch on top of plastic bag.

Pull first wipe from the center of roll up through opening of bag.

Thread first wipe through the dispensing nozzle in lid of floor stand or dispenser.

Close dipenser door. Wipe dispensing tension may be adjusted on top of dispenser. Dispenser must be mounted with wipes dispensing up.

Active Ingredients

Benzalkonium chloride 0.13%

Inactive Ingredients

Water (Aqua), Propylene Glycol, Polysorbate 20, Disodium Cocoamphodiacetate, Citric Acid, Disodium EDTA, Potassium Sorbate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Fragrance.

Structured Label Content

Uses (USES)

For hand sanitizing to decrease bacteria on the skin.

Apply topically to the skin to help prevent cross contamination.

Recommended for repeated use.

Dries in seconds.

Section 50565-1 (50565-1)

Keep out of the reach of children unless under adult supervision

Section 51945-4 (51945-4)

800 CT REFILL, NDC: 81244-001-01

Purpose

Antiseptic

Warnings (WARNINGS)

For external use only

May irritate eyes

Keep out of the reach of children unless under adult supervision

Directions (DIRECTIONS)

Tear V notch on top of plastic bag.

Pull first wipe from the center of roll up through opening of bag.

Thread first wipe through the dispensing nozzle in lid of floor stand or dispenser.

Close dipenser door. Wipe dispensing tension may be adjusted on top of dispenser. Dispenser must be mounted with wipes dispensing up.

Active Ingredients (ACTIVE INGREDIENTS)

Benzalkonium chloride 0.13%

Inactive Ingredients (INACTIVE INGREDIENTS)

Water (Aqua), Propylene Glycol, Polysorbate 20, Disodium Cocoamphodiacetate, Citric Acid, Disodium EDTA, Potassium Sorbate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Fragrance.

Advanced Ingredient Data

[{"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": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DISODIUM COCOAMPHODIACETATE", "unii": "18L9G3U51M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM ANHYDROUS", "unii": "8NLQ36F6MM", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FRAGRANCE LEMON ORC2001060", "unii": "K1725A7G95", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USES": "For hand sanitizing to decrease bacteria on the skin. Apply topically to the skin to help prevent cross contamination. Recommended for repeated use. Dries in seconds.", "50565-1": "Keep out of the reach of children unless under adult supervision", "51945-4": "800 CT REFILL, NDC: 81244-001-01", "Purpose": "Antiseptic", "WARNINGS": "For external use only May irritate eyes Keep out of the reach of children unless under adult supervision", "DIRECTIONS": "Tear V notch on top of plastic bag. Pull first wipe from the center of roll up through opening of bag. Thread first wipe through the dispensing nozzle in lid of floor stand or dispenser. Close dipenser door. Wipe dispensing tension may be adjusted on top of dispenser. Dispenser must be mounted with wipes dispensing up.", "ACTIVE INGREDIENTS": "Benzalkonium chloride 0.13%", "INACTIVE INGREDIENTS": "Water (Aqua), Propylene Glycol, Polysorbate 20, Disodium Cocoamphodiacetate, Citric Acid, Disodium EDTA, Potassium Sorbate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Fragrance."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:42.624590 · Updated: 2026-03-14T23:01:30.191020