Drug Fact

Drug Fact
SPL v1
SPL
SPL Set ID 5f9ebfaa-189e-48c1-a220-ebd3517f38ef
Route
TOPICAL
Published
Effective Date 2011-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 g)
Inactive Ingredients
Water Carbomer Copolymer Type A Trolamine Alpha-tocopherol Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-05-07
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

  • Wet hands thoroughly with product and allow to dry without wiping
  • For children under 6, use only under adult supervision
  • Not recommended for infants
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:

Carbomer, Water, Triethanolamine, Fragrance, Tocopherol, FD and C Blue No. 1, FD and C Yellow No. 5.

Section 51945-4

labe

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

  • Wet hands thoroughly with product and allow to dry without wiping
  • For children under 6, use only under adult supervision
  • Not recommended for infants
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:

Carbomer, Water, Triethanolamine, Fragrance, Tocopherol, FD and C Blue No. 1, FD and C Yellow No. 5.

Section 51945-4 (51945-4)

labe

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: 2026-02-15T11:55:14.835159 · Updated: 2026-03-14T22:52:38.637108