Drug Fact

Drug Fact
SPL v1
SPL
SPL Set ID 282e60d3-3c6f-47f2-bc88-7b3c09c4dcad
Route
TOPICAL
Published
Effective Date 2012-12-24
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 2012-12-18
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 thoroughly with water.  Avoid Contact with broken skin. Do not inhale or ingest.



Indications and Usage

Uses

To decrease bacteria on the skin that could cause diseases

Dosage and Administration

Directions

  • Wet hands thoroughly with product and allow to dry without wiping
Description

Active Ingredient Ethyl Alcohol 63%

Section 44425-7

Other Information:

  • Do not store above 105F
  • May discolor some fabrics
Section 50565-1

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately

Section 50569-3

Stop use and ask a doctor if skin irritation develops

Section 51727-6

Inactive Ingredient:

Deionized Water, Triethanolamine, Carbomer, Fragrance, 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 that could cause diseases

Dosage and Administration (34068-7)

Directions

  • Wet hands thoroughly with product and allow to dry without wiping
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 thoroughly with water.  Avoid Contact with broken skin. Do not inhale or ingest.



Section 44425-7 (44425-7)

Other Information:

  • Do not store above 105F
  • May discolor some fabrics
Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately

Section 50569-3 (50569-3)

Stop use and ask a doctor if skin irritation develops

Section 51727-6 (51727-6)

Inactive Ingredient:

Deionized Water, Triethanolamine, Carbomer, Fragrance, 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: 2026-02-15T11:55:34.280740 · Updated: 2026-03-14T22:53:21.930902