SPL v2
SPL
SPL Set ID a2e81b3a-714b-0d8d-e053-2a95a90ae205
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.68 mL)
Inactive Ingredients
Glycerin Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Water Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30
Description

Ethyl Alcohol 68%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 68%

Uses

Decrease bacteria on hands

Recommended for repeated use.

Warnings

For external use only.

Flammable - Keep away from fire or flame

Directions
  • Apply a small amount onto hands and rub briskly until dry.
  • Supervise children in the use of this product.
Other Information
  • Read the directions and warnings before use.
  • Do not use for other purposes.
  • Store at 1-30oC (33.8-86oF).
Active Ingredient(s)

Ethyl Alcohol 68%

Inactive Ingredients

Water, Glycerin, Carbomer, Triethanolamine

When Using This Product

avoid contact with eyes.

if contact occurs, rinse thoroughly with waterr

Stop Use and Ask A Doctor

if irritation and redness develop or increase.

Keep Out of Reach of Children

if swallowed, get medical help or contact a Poison Control Center right away.

Package Label Principal Display Panel

500 mL NDC: 73330-0010-1

250 mL NDC: 73330-0010-2

100 mL NDC: 73330-0010-3

Structured Label Content

Uses

Decrease bacteria on hands

Recommended for repeated use.

Purpose

Antiseptic

Warnings

For external use only.

Flammable - Keep away from fire or flame

Directions
  • Apply a small amount onto hands and rub briskly until dry.
  • Supervise children in the use of this product.
Other Information (Other information)
  • Read the directions and warnings before use.
  • Do not use for other purposes.
  • Store at 1-30oC (33.8-86oF).
Active Ingredient(s)

Ethyl Alcohol 68%

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Carbomer, Triethanolamine

When Using This Product (When using this product)

avoid contact with eyes.

if contact occurs, rinse thoroughly with waterr

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if irritation and redness develop or increase.

Keep Out of Reach of Children (Keep out of reach of children)

if swallowed, get medical help or contact a Poison Control Center right away.

Package Label Principal Display Panel (Package Label - Principal Display Panel)

500 mL NDC: 73330-0010-1

250 mL NDC: 73330-0010-2

100 mL NDC: 73330-0010-3

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:57.135332 · Updated: 2026-03-14T22:57:15.604123