Drug Fact

Drug Fact
SPL v1
SPL
SPL Set ID abb9c0b2-3109-4cde-9fe5-07eaa23e4ce6
Route
TOPICAL
Published
Effective Date 2013-11-06
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 2013-11-09
Description

Active Ingredient Ethyl Alcohol 63%

Medication Information

Warnings and Precautions

For external use only.

When using this product: Keep out of eyes. Do not 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 42229-5

Other Information

Do not store above 105F

May discolor some fabrics

Section 50565-1

Keep out of reach of children.

If swallowed, get medical assistance.

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

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.

When using this product: Keep out of eyes. Do not ingest.

 

Section 42229-5 (42229-5)

Other Information

Do not store above 105F

May discolor some fabrics

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical assistance.

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)

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: 2026-02-15T11:55:42.913286 · Updated: 2026-03-14T22:53:37.408704