Drug Fact

Drug Fact
SPL v1
SPL
SPL Set ID 295d4366-09b2-460a-b288-f47fa0e8d85b
Route
TOPICAL
Published
Effective Date 2013-09-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (63 mL)
Inactive Ingredients
Water Carbomer Copolymer Type A Trolamine Edetate Disodium D&c Red No. 33 Fd&c Blue No. 1 Fd&c Yellow No. 5 Fd&c Yellow No. 6 Fd&c Red No. 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-07-09
Description

Active Ingredient Ethyl Alcohol 63%

Medication Information

Warnings and Precautions

For external use only, hands. Flammable,  keep away from heat and flame.

When using this product: Keep out of eyes. In case of contact with eyes, flush throughly with water.

Avoid contact with broken skin. Do not inhale or ingest.

 



Indications and Usage

Uses

To decrease bacteria on the skin

Dosage and Administration

Directions

  • Rub a dime size drop into hands

Description

Active Ingredient Ethyl Alcohol 63%

Section 50565-1

Keep out of reach of children.

Section 50569-3

Stop use and ask a doctor if skin irritation develops

Section 51727-6

Inactive Ingredient:

Aqua, Carbomer, Triethanolamine, Parfum, Disodium EDTA, may contain D and C Red No. 33, FD and C Red No. 40, FD and C Blue No. 1, FD and C Yellow No. 5, FD and C Yellow No. 6.

Section 51945-4

lab

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredient

Ethyl Alcohol 63%

Structured Label Content

Indications and Usage (34067-9)

Uses

To decrease bacteria on the skin

Dosage and Administration (34068-7)

Directions

  • Rub a dime size drop into hands

Warnings and Precautions (34071-1)

For external use only, hands. Flammable,  keep away from heat and flame.

When using this product: Keep out of eyes. In case of contact with eyes, flush throughly with water.

Avoid contact with broken skin. Do not inhale or ingest.

 



Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50569-3 (50569-3)

Stop use and ask a doctor if skin irritation develops

Section 51727-6 (51727-6)

Inactive Ingredient:

Aqua, Carbomer, Triethanolamine, Parfum, Disodium EDTA, may contain D and C Red No. 33, FD and C Red No. 40, FD and C Blue No. 1, FD and C Yellow No. 5, FD and C Yellow No. 6.

Section 51945-4 (51945-4)

lab

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredient

Ethyl Alcohol 63%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:41.615082 · Updated: 2026-03-14T22:53:35.209708