Drug Fact

Drug Fact
SPL v1
SPL
SPL Set ID 449d0b9c-f7b3-4986-ab25-fcfc2a033921
Route
TOPICAL
Published
Effective Date 2010-05-03
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 Blue No. 1 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-05-20
Description

Active Ingredient                        Purpose Ethyl Alcohol 62%                      Antiseptic

Medication Information

Warnings and Precautions

Warnings:

For external use only-hands.

Flammable-keep away from heat and flame

When using this products

  • 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



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                        Purpose Ethyl Alcohol 62%                      Antiseptic

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, Fragrance (Parfume), PEG-40 Hydrogenated Castor Oil, Carbomer, DMDM hydantoin, Hydrogenated Jojoba Oil,, D and C Red No. 33, FD and C Blue No. 1

Section 51945-4

pict

Section 55106-9

Active Ingredient                        Purpose

Ethyl Alcohol 62%                      Antiseptic

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

When using this products

  • 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



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, Fragrance (Parfume), PEG-40 Hydrogenated Castor Oil, Carbomer, DMDM hydantoin, Hydrogenated Jojoba Oil,, D and C Red No. 33, FD and C Blue No. 1

Section 51945-4 (51945-4)

pict

Section 55106-9 (55106-9)

Active Ingredient                        Purpose

Ethyl Alcohol 62%                      Antiseptic

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:03.283380 · Updated: 2026-03-14T22:52:22.069763