Drug Fact

Drug Fact
SPL v1
SPL
SPL Set ID 6a00b903-fd2a-4c27-ac25-51c33b20fb31
Route
TOPICAL
Published
Effective Date 2012-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 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 2012-06-18
Description

Active Ingredient Ethyl Alcohol  62%

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

Recommended for repeated use

Dosage and Administration

Directions

  • Rub a small amount onto palms of hands to kill unwanted germs and bacteria.

Description

Active Ingredient Ethyl Alcohol  62%

Section 44425-7

Other Information:

  • Do not store above 105F
  • May discolor some fabrics
  • Harmful to wood finishes and plastics

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  62%

Structured Label Content

Indications and Usage (34067-9)

Uses

To decrease bacteria on the skin that could cause diseases

Recommended for repeated use

Dosage and Administration (34068-7)

Directions

  • Rub a small amount onto palms of hands to kill unwanted germs and bacteria.

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
  • Harmful to wood finishes and plastics

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  62%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:29.833801 · Updated: 2026-03-14T22:53:14.066899