SPL v2
SPL
SPL Set ID a2ff45e6-a0e1-18f8-e053-2995a90a2d4a
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (0.7 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 70%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70%

Uses

Hand sanitizer to help decrease bacteria on the skin.

Recommended for repeated use.

Warnings

Flammable - Keep away from fire or flame

For EXTERNAL use only.

Directions
  • Apply palmful to hands. Rub hands together vigorously 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 70%

Inactive Ingredients

Water, Glycerin, Carbomer, Triethanolamine

When Using This Product
  • Do not use in or near eyes.
  • In case of contact, rinse thoroughly with water.
Stop Use and Ask A Doctor

if irritation and redness develops.

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: 73330-0011-1

250 mL NDC: 73330-0011-2

100 mL NDC: 73330-0011-3


Structured Label Content

Uses

Hand sanitizer to help decrease bacteria on the skin.

Recommended for repeated use.

Purpose

Antiseptic

Warnings

Flammable - Keep away from fire or flame

For EXTERNAL use only.

Directions
  • Apply palmful to hands. Rub hands together vigorously 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 70%

Inactive Ingredients (Inactive ingredients)

Water, Glycerin, Carbomer, Triethanolamine

When Using This Product (When using this product)
  • Do not use in or near eyes.
  • In case of contact, rinse thoroughly with water.
Stop Use and Ask A Doctor (Stop use and ask a doctor)

if irritation and redness develops.

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: 73330-0011-1

250 mL NDC: 73330-0011-2

100 mL NDC: 73330-0011-3


Advanced Ingredient Data


Raw Label Data

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