a8e1fa9e-b90e-bf0d-e053-2995a90a5a56

SPL v1
SPL
SPL Set ID a8e1fa9e-b90e-bf0d-e053-2995a90a5a56
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
Purpose

Antiseptic

Description

Ethyl Alcohol 68%

Medication Information

Warnings

For external use only.

Flammable - Keep away from fire or flame

Uses

Decrease bacteria on hands

Recommended for repeated use.

Purpose

Antiseptic

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 1-30℃ (33.8-86℉).
Inactive Ingredients

Water, Glycerin, Carbomer, Triethanolamine

Description

Ethyl Alcohol 68%

Active Ingredient(s)

Ethyl Alcohol 68%

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: 73330-0016-1

Structured Label Content

Warnings

For external use only.

Flammable - Keep away from fire or flame

Uses

Decrease bacteria on hands

Recommended for repeated use.

Purpose

Antiseptic

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 1-30℃ (33.8-86℉).
Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Carbomer, Triethanolamine

Active Ingredient(s)

Ethyl Alcohol 68%

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: 73330-0016-1

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:02.549822 · Updated: 2026-03-14T22:57:24.728228