8hd Hand And Skin Sanitizer

SPL v2

SPL

SPL Set ID b68a4cf8-0214-7dad-e053-2a95a90a04f5

Route

TOPICAL

Published

Effective Date 2020-12-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.04 g)

Inactive Ingredients

Hydrated Silica Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-12-16

Description

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Benzalkonium Chloride 0.13%

Uses:

Sanitizes hands and skin to help reduce bacteria that potentially cause diseases.

Warnings:

For external use only.

Do Not Use

in eyes. If contact occurs, flush thoroughly with water.

Directions:

On dry hands, place enough product in your palms to thoroughly cover the targeted area. Rub briskly until entirely dry.

Active Ingredient

Benzalkonium Chloride 0.13%

Inactive Ingredients:

Water, Hydrated Silica Complex

Stop Use and Ask A Doctor:

If irritation or redness develops, or if condition persists for more than 72 hours.

Package Labeling:72513 200 01

Package Labeling:72513 200 02

Package Labeling:72513 200 03

Package Labeling:72513 200 04

Package Labeling:72513 200 05

Package Labeling:72513 200 06

Package Labeling:72513 200 07

Keep Out of Reach of Children:

If swallowed, get medical help or contact a Poison Control Center.

Structured Label Content

Uses: (USES:)

Sanitizes hands and skin to help reduce bacteria that potentially cause diseases.

Purpose (PURPOSE)

Antimicrobial

Warnings: (WARNINGS:)

For external use only.

Do Not Use (Do not use)

in eyes. If contact occurs, flush thoroughly with water.

Directions: (DIRECTIONS:)

On dry hands, place enough product in your palms to thoroughly cover the targeted area. Rub briskly until entirely dry.

Active Ingredient (ACTIVE INGREDIENT)

Benzalkonium Chloride 0.13%

Inactive Ingredients:

Water, Hydrated Silica Complex

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

If irritation or redness develops, or if condition persists for more than 72 hours.

Package Labeling:72513 200 01 (Package Labeling:72513-200-01)

Package Labeling:72513 200 02 (Package Labeling:72513-200-02)

Package Labeling:72513 200 03 (Package Labeling:72513-200-03)

Package Labeling:72513 200 04 (Package Labeling:72513-200-04)

Package Labeling:72513 200 05 (Package Labeling:72513-200-05)

Package Labeling:72513 200 06 (Package Labeling:72513-200-06)

Package Labeling:72513 200 07 (Package Labeling:72513-200-07)

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

If swallowed, get medical help or contact a Poison Control Center.

Advanced Ingredient Data

[{"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "0.04", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "99.83", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"USES:": "Sanitizes hands and skin to help reduce bacteria that potentially cause diseases.", "PURPOSE": "Antimicrobial", "WARNINGS:": "For external use only.", "Do not use": "in eyes. If contact occurs, flush thoroughly with water.", "DIRECTIONS:": "On dry hands, place enough product in your palms to thoroughly cover the targeted area. Rub briskly until entirely dry.", "ACTIVE INGREDIENT": "Benzalkonium Chloride 0.13%", "Inactive Ingredients:": "Water, Hydrated Silica Complex", "Stop use and ask a doctor:": "If irritation or redness develops, or if condition persists for more than 72 hours.", "Keep out of reach of children:": "If swallowed, get medical help or contact a Poison Control Center."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:33.546628 · Updated: 2026-03-14T23:02:10.811423