SPL v1
SPL
SPL Set ID 2e2b3a15-4caa-42a1-a5ae-61ca4d941713
Route
TOPICAL
Published
Effective Date 2020-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (80 mL)
Inactive Ingredients
Water Glycerin Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Triisopropanolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-10
Description

Ethyl Alcohol 80% v/v

Purpose

Antimicrobial

Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 80% v/v

Uses

hand sanitizer to help reduce bacteria on the skin 

Section 50565-1

Warnings

Flammable, keep away from fire or flame

For external use only

When using this product do not use in or near the eyes

In case of contact rinse thoroughly with water 

Directions
  • Put enough product in your palm to cover hands and rub hands together briskly until dry.
  • children under 6 years of age should be supervised when using this PREMIER PURE
Product Label

Active Ingredient

Ethyl Alcohol 80% v/v

Other Information
  • Store below 1100 F (430C)
  •  May discolor certain fabrics or surfaces 
  • This product does not contain any chemicals known to the State of California to cause cancer, birth defects, or any other reproductive harm
Inactive Ingredients

Water, Glycerin, Propylene Glycol, Triisopropanolamine, Carbomer, Fragrance

When Using This Product

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water

Stop Use and Ask Doctor If

irritation or rash appears and lasts

Keep Out of Reach of Children.

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

Structured Label Content

Uses

hand sanitizer to help reduce bacteria on the skin 

Section 50565-1 (50565-1)

Purpose

Antimicrobial

Warnings

Flammable, keep away from fire or flame

For external use only

When using this product do not use in or near the eyes

In case of contact rinse thoroughly with water 

Directions
  • Put enough product in your palm to cover hands and rub hands together briskly until dry.
  • children under 6 years of age should be supervised when using this PREMIER PURE
Product Label

Active Ingredient (Active ingredient)

Ethyl Alcohol 80% v/v

Other Information (Other information)
  • Store below 1100 F (430C)
  •  May discolor certain fabrics or surfaces 
  • This product does not contain any chemicals known to the State of California to cause cancer, birth defects, or any other reproductive harm
Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Propylene Glycol, Triisopropanolamine, Carbomer, Fragrance

When Using This Product (When using this product)

do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water

Stop Use and Ask Doctor If (Stop use and ask doctor if)

irritation or rash appears and lasts

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

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:11.951723 · Updated: 2026-03-14T22:56:09.845676