Hand Sanitizer

SPL v1

SPL

SPL Set ID f4a330af-fb95-456a-9d43-375de339d463

Route

TOPICAL

Published

Effective Date 2024-05-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (620 mg)

Inactive Ingredients

Carbomer Homopolymer, Unspecified Type Glycerin Propylene Glycol .alpha.-tocopherol Acetate Trolamine Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-05-01

Description

Ethyl Alcohol 62%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 62%

Uses

• For Hand Sanitizing

Warnings

For external use only - hands.

Flammable. Keep away from heat and flame.

Directions

• Wet hands thoroughly with product and allow to dry without wiping.

• For children under age 6, use only under adult supervision.

• Not recommended for infants.

Active Ingredient

Ethyl Alcohol 62%

Other Information

• Do not store above 105 F.

• May discolor some fabrics.

Package Labeling:

Inactive Ingredients

Carbomer, Fragrance, Glycerin,Propylene Glycol, Tocopheryl Acetate, Triethanolamine,Water

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 Outof Reachof Children.

If swallowed, get medical help or call a Poison Control Center right away

Structured Label Content

Uses

• For Hand Sanitizing

Purpose

Antiseptic

Warnings

For external use only - hands.

Flammable. Keep away from heat and flame.

Directions

• Wet hands thoroughly with product and allow to dry without wiping.

• For children under age 6, use only under adult supervision.

• Not recommended for infants.

Active Ingredient

Ethyl Alcohol 62%

Other Information

• Do not store above 105 F.

• May discolor some fabrics.

Package Labeling:

Inactive Ingredients

Carbomer, Fragrance, Glycerin,Propylene Glycol, Tocopheryl Acetate, Triethanolamine,Water

When Using This Product (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 (Stop use and ask a doctor)

if skin irritation develops.

Keep Outof Reachof Children. (Keep outof reachof children.)

If swallowed, get medical help or call a Poison Control Center right away

Advanced Ingredient Data

[{"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "620", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "• For Hand Sanitizing", "Purpose": "Antiseptic", "Warnings": "For external use only - hands. Flammable. Keep away from heat and flame.", "Directions": "• Wet hands thoroughly with product and allow to dry without wiping. • For children under age 6, use only under adult supervision. • Not recommended for infants.", "Active Ingredient": "Ethyl Alcohol 62%", "Other Information": "• Do not store above 105 F. • May discolor some fabrics.", "Inactive Ingredients": "Carbomer, Fragrance, Glycerin,Propylene Glycol, Tocopheryl Acetate, Triethanolamine,Water", "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 outof reachof children.": "If swallowed, get medical help or call a Poison Control Center right away"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:04.875419 · Updated: 2026-03-14T23:02:55.861635