Drug Fact

Drug Fact
SPL v1
SPL
SPL Set ID f5716779-47d9-4208-9e67-017aaded81ee
Route
TOPICAL
Published
Effective Date 2011-06-09
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 Glycerin Fd&c Blue No. 1 Dmdm Hydantoin Fd&c Yellow No. 5 Fd&c Red No. 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-06-27
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, Glycerin, Triethanolamine, Fragrance, Peg-40 Hydrogenated Castor Oil, DMDM Hydantoin, FD and C Red No. 40, FD and C Blue No. 1, FD and C Yellow No. 5

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

  • 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, Glycerin, Triethanolamine, Fragrance, Peg-40 Hydrogenated Castor Oil, DMDM Hydantoin, FD and C Red No. 40, FD and C Blue No. 1, FD and C Yellow No. 5

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: 2026-02-15T11:55:16.112376 · Updated: 2026-03-14T22:52:41.001711