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SPL v1

SPL

SPL Set ID a852a366-2fa9-4e8e-bfc5-35dded8ca0da

Route

TOPICAL

Published

Effective Date 2021-04-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (70.0984 L)

Inactive Ingredients

Glycerin Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2021-04-05

Description

Alcohol 75% v/v

Purpose

Antimicrobial

Medication Information

Warnings and Precautions

Warnings: For external use only. Flammable. Keep away from fire or flame.

Indications and Usage

Uses Hand sanitizer to help reduce bacteria on the skin.

Purpose

Antimicrobial

Dosage and Administration

Directions: Wet hands thoroughly with product and allow to dry.

Description

Alcohol 75% v/v

Section 44425-7

Other Information Store under 105°F.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Section 50567-7

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts.

Section 51727-6

Inactive Ingredients Purified water, Glycerin USP

Section 51945-4

Active Ingredients

Alcohol 75% v/v

Structured Label Content

Indications and Usage (34067-9)

Uses Hand sanitizer to help reduce bacteria on the skin.

Dosage and Administration (34068-7)

Directions: Wet hands thoroughly with product and allow to dry.

Warnings and Precautions (34071-1)

Warnings: For external use only. Flammable. Keep away from fire or flame.

Section 44425-7 (44425-7)

Other Information Store under 105°F.

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 50567-7 (50567-7)

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts.

Section 51727-6 (51727-6)

Inactive Ingredients Purified water, Glycerin USP

Section 51945-4 (51945-4)

Purpose

Antimicrobial

Active Ingredients

Alcohol 75% v/v

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70.0984", "strengthDenominator": "100", "strengthNumeratorUnit": "L", "strengthDenominatorUnit": "L"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "0.0678", "strengthDenominator": "100", "strengthNumeratorUnit": "L", "strengthDenominatorUnit": "L"}, {"name": "water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "29.8338", "strengthDenominator": "100", "strengthNumeratorUnit": "L", "strengthDenominatorUnit": "L"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses Hand sanitizer to help reduce bacteria on the skin.", "34068-7": "Directions: Wet hands thoroughly with product and allow to dry.", "34071-1": "Warnings: For external use only. Flammable. Keep away from fire or flame.", "44425-7": "Other Information Store under 105°F. ", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.", "50567-7": "When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash appears and lasts.", "51727-6": "Inactive Ingredients Purified water, Glycerin USP", "Purpose": "Antimicrobial", "Active Ingredients": "Alcohol 75% v/v"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:29.258077 · Updated: 2026-03-14T22:59:29.411693