Drug Fact

Drug Fact
SPL v1
SPL
SPL Set ID dc620956-0e71-4710-b22c-4fa60f2f4ddd
Route
TOPICAL
Published
Effective Date 2010-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 g)
Inactive Ingredients
Water Glycerin Trolamine Carbomer Homopolymer Type A Polyoxyl 40 Hydrogenated Castor Oil Dmdm Hydantoin Fd&c Yellow No. 5 Fd&c Blue No. 1 Fd&c Red No. 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-08-07
Description

Active Ingredient       Ethyl Alcohol     62% Purpose                      Antiseptic 

Medication Information

Warnings and Precautions

Warnings:

For external use only

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

Stop use and ask a doctor if skin irritation develops

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

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

Uses: 

To decrease bacteria on skin that could cause disease

Recommended for repeated use

Section 44425-7
Other Information



  • Do not store above 105F
  • May discolor some fabrics
  • Harmful to wood finishes and plastics
Section 51727-6


Inactive Ingredients:



Water, Glycerin, Triethanolamine, Carbomer, Fragrance, PEG-40 Hydrogenated Castor Oil, DMDM Hydantoin, Hydrogenated Jojoba Oil, FDA and C Blue No. 1, FD and C Red No. 40, FD and C Yellow No. 5

Section 51945-4

labe

Section 55106-9

Active Ingredient      Ethyl Alcohol     62%

Purpose                      Antiseptic 

Structured Label Content

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)

Warnings:

For external use only

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

Stop use and ask a doctor if skin irritation develops

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

Description (34089-3)

Uses: 

To decrease bacteria on skin that could cause disease

Recommended for repeated use

Section 44425-7 (44425-7)
Other Information



  • Do not store above 105F
  • May discolor some fabrics
  • Harmful to wood finishes and plastics
Section 51727-6 (51727-6)


Inactive Ingredients:



Water, Glycerin, Triethanolamine, Carbomer, Fragrance, PEG-40 Hydrogenated Castor Oil, DMDM Hydantoin, Hydrogenated Jojoba Oil, FDA and C Blue No. 1, FD and C Red No. 40, FD and C Yellow No. 5

Section 51945-4 (51945-4)

labe

Section 55106-9 (55106-9)

Active Ingredient      Ethyl Alcohol     62%

Purpose                      Antiseptic 

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:06.515872 · Updated: 2026-03-14T22:52:26.166879