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SPL v1

SPL

SPL Set ID a45c7476-3731-0a7b-e053-2a95a90a304d

Route

TOPICAL

Published

Effective Date 2020-04-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (0.5 mL)

Inactive Ingredients

Aminomethylpropanol Water Glycerin Fragrance Lavender & Chia F-153480 Propylene Glycol Polyacrylic Acid (8000 Mw)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-04-30

Description

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Purpose

Antiseptic, Hand sanitizer

Medication Information

Purpose

Antiseptic, Hand sanitizer

Description

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Use

Hand sanitizer for hand-washing to decrease bacteria on the skin, only when water is not available

Section 50565-1

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

Section 51945-4

500 mL NDC: 75192-100-01

Warnings

Flammable, keep away from fire and flames

For external use only

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Active Ingredient(s)

Ethyl alcohol 70%

Inactive Ingredients

water, glycerin, aminomethylpropanol, propylene glycol, polyacrylic acid, and fragrance

Structured Label Content

Use

Hand sanitizer for hand-washing to decrease bacteria on the skin, only when water is not available

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

500 mL NDC: 75192-100-01

Purpose

Antiseptic, Hand sanitizer

Warnings

Flammable, keep away from fire and flames

For external use only

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing.

Active Ingredient(s)

Ethyl alcohol 70%

Inactive Ingredients (Inactive ingredients)

water, glycerin, aminomethylpropanol, propylene glycol, polyacrylic acid, and fragrance

Advanced Ingredient Data

[{"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "0.5", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "27.85", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "0.85", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "FRAGRANCE LAVENDER & CHIA F-153480", "unii": "SXS9CO2TZK", "classCode": "IACT", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "0.3", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "POLYACRYLIC ACID (8000 MW)", "unii": "73861X4K5F", "classCode": "IACT", "strengthNumerator": "0.3", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use": "Hand sanitizer for hand-washing to decrease bacteria on the skin, only when water is not available", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "51945-4": "500 mL NDC: 75192-100-01", "Purpose": "Antiseptic, Hand sanitizer", "Warnings": "Flammable, keep away from fire and flames For external use only", "Directions": "Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.", "Active Ingredient(s)": "Ethyl alcohol 70%", "Inactive ingredients": "water, glycerin, aminomethylpropanol, propylene glycol, polyacrylic acid, and fragrance"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:23.770618 · Updated: 2026-03-14T22:56:31.394385