Drug Fact

Drug Fact
SPL v1
SPL
SPL Set ID 16034385-2b53-46f1-964e-96b1ad17cd57
Route
TOPICAL
Published
Effective Date 2010-03-04
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 Red No. 40

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-03-20
Description

Active Ingredient Ethyl Alcohol 62%

Medication Information

Warnings and Precautions

Warnings:

For external use only-hands.

Flammable-keep away from heat and flame



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 105 F
  • May discolor some fabrics
  • Harmful to wood finishes and plastics

Section 51727-6

Inactive Ingredients

Water (aqua), Glycerin, Triethanolamine, Carbomer,Fragrance (Parfume), PEG-40 hydrogenated castor oil, DMDM hydantoin, Hydrogenated Jojoba Oil, FD and C Yellow No. 5, FD and C Red No. 40

Section 51945-4

picture

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)

Warnings:

For external use only-hands.

Flammable-keep away from heat and flame



Section 44425-7 (44425-7)

    Other Information

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

Section 51727-6 (51727-6)

Inactive Ingredients

Water (aqua), Glycerin, Triethanolamine, Carbomer,Fragrance (Parfume), PEG-40 hydrogenated castor oil, DMDM hydantoin, Hydrogenated Jojoba Oil, FD and C Yellow No. 5, FD and C Red No. 40

Section 51945-4 (51945-4)

picture

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: 2026-02-15T11:55:01.451379 · Updated: 2026-03-14T22:52:20.145878