47993-258

47993-258
SPL v2
SPL
SPL Set ID a57e9c5d-5e5e-cc59-e053-2a95a90a1085
Route
TOPICAL
Published
Effective Date 2020-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (62 g)
Inactive Ingredients
Carbomer 940 Aloe Vera Leaf Water Glycerin Triethanolamine Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-13
Description

Active ingredients Ethyl Alcohol 62%

Medication Information

Warnings and Precautions

Warnings:

For external use only：hands

Flammable，keep away from fire or flame.

Indications and Usage

Uses：

  • To decrease bacteria on the skin that could cause disease.
  • 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 ingredients Ethyl Alcohol 62%

Section 50565-1

For children under 6，use only under adult supervision.

Section 50566-9

Stop use and ask a doctor if

  • Irritation or redness develops.
  • Condition persists for more than 72 hours.
Section 50567-7

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 51727-6

Inactive Ingredients:

Water,Carbomer 940,Triethanolamine,Glycerin,Aloe Barbadensis leaf juice

Section 51945-4

Section 55105-1

Antiseptic

Section 55106-9

Active ingredients

Ethyl Alcohol 62%

Section 60561-8

Other information

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

Structured Label Content

Indications and Usage (34067-9)

Uses：

  • To decrease bacteria on the skin that could cause disease.
  • 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 fire or flame.

Section 50565-1 (50565-1)

For children under 6，use only under adult supervision.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • Irritation or redness develops.
  • Condition persists for more than 72 hours.
Section 50567-7 (50567-7)

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 51727-6 (51727-6)

Inactive Ingredients:

Water,Carbomer 940,Triethanolamine,Glycerin,Aloe Barbadensis leaf juice

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antiseptic

Section 55106-9 (55106-9)

Active ingredients

Ethyl Alcohol 62%

Section 60561-8 (60561-8)

Other information

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:59.653935 · Updated: 2026-03-14T22:58:49.351511