SPL v3
SPL
SPL Set ID af5b5098-5fda-9330-e053-2995a90a265f
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Glycerin Trolamine Propylene Glycol Carbomer 940

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-14
Description

Ethyl Alcohol 70% v/v.

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70% v/v.

Section 50565-1

If swallowed, get medical help or contact a poison control center right away.

Warnings

For external use only hands

Directions

put a thumbnail size amount in your palm and rub your hands together briskly until dry.

When Using

Flammable, keep away from fire or flame. When using this product: Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Other Information

Do you not store above 100F (38C) May discolor some fabrics. Harmful to wood finishes and plastics.

Active Ingredient(s)

Ethyl Alcohol 70% v/v.

Inactive Ingredients

Demineralized water, Glycerin, Carbomer, Triethanolamine, Propylene glycol

Package Label Principal Display Panel

100 mL NDC: 80565-001-01

100 mL NDC: 80565-001-11

250 mL NDC: 80565-001-25

500 mL NDC: 80565-001-05

5000 mL NDC: 80565-001-50

1000 mL NDC: 80565-001-10

Structured Label Content

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a poison control center right away.

Purpose

Antiseptic

Warnings

For external use only hands

Directions

put a thumbnail size amount in your palm and rub your hands together briskly until dry.

When Using

Flammable, keep away from fire or flame. When using this product: Keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Other Information (Other information)

Do you not store above 100F (38C) May discolor some fabrics. Harmful to wood finishes and plastics.

Active Ingredient(s)

Ethyl Alcohol 70% v/v.

Inactive Ingredients (Inactive ingredients)

Demineralized water, Glycerin, Carbomer, Triethanolamine, Propylene glycol

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

100 mL NDC: 80565-001-01

100 mL NDC: 80565-001-11

250 mL NDC: 80565-001-25

500 mL NDC: 80565-001-05

5000 mL NDC: 80565-001-50

1000 mL NDC: 80565-001-10

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:50.642830 · Updated: 2026-03-14T22:58:36.589882