SPL v7
SPL
SPL Set ID ecc8ee22-cf81-4964-80d3-79711875428e
Route
TOPICAL
Published
Effective Date 2012-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (400 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-12-01

Description

Ethyl Alcohol, 80%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Ethyl Alcohol, 80%

Uses

For hand cleaning to decrease bacteria on the skin.

Recommended for repeated use.

Warnings

For external use only.

Flammable. Keep away from fire or flame. No Smoking.

Directions
  • apply a palmful to hands
  • scrub thoroughly until dry
Active Ingredient

Ethyl Alcohol, 80%

Inactive Ingredients

water panthenol, glycerin, cetyl alcohol, propylene glycol.

When Using This Product

avoid contact with face, eyes and broken skin. If eye contact occurs, rinse eyes thoroughly with water and seek medical advice.

Contents Under Pressure.

Do not puncture or incinerate. Do not store at temperatures above 120°F (50°C).

For Questions Or Comments

or to report any adverse reactions or side effects, please call 1-800-233-9382.

Stop Use and Ask A Doctor

if irritation or redness develops.

Keep Out of Reach of Children.

If swallowed get medical help, or contact a poison control center immediately.

Carton Label Package of 6 Cans

Principal Display Panel Label On Individual Unit Can


Structured Label Content

Uses

For hand cleaning to decrease bacteria on the skin.

Recommended for repeated use.

Purpose

Antibacterial

Warnings

For external use only.

Flammable. Keep away from fire or flame. No Smoking.

Directions
  • apply a palmful to hands
  • scrub thoroughly until dry
Active Ingredient

Ethyl Alcohol, 80%

Inactive Ingredients

water panthenol, glycerin, cetyl alcohol, propylene glycol.

When Using This Product (When using this product)

avoid contact with face, eyes and broken skin. If eye contact occurs, rinse eyes thoroughly with water and seek medical advice.

Contents Under Pressure. (Contents under pressure.)

Do not puncture or incinerate. Do not store at temperatures above 120°F (50°C).

For Questions Or Comments (For questions or comments)

or to report any adverse reactions or side effects, please call 1-800-233-9382.

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

if irritation or 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 immediately.

Carton Label Package of 6 Cans (Carton Label -- package of 6 cans)

Principal Display Panel Label On Individual Unit Can (Principal Display Panel -- Label on individual unit can)


Advanced Ingredient Data


Raw Label Data

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