antiseptic hand sanitizer

antiseptic hand sanitizer
SPL v4
SPL
SPL Set ID b7f00c15-852f-45ce-9c60-70e0b80234f5
Route
topical
Published
Effective Date 2022-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (620 mg)
Inactive Ingredients
water

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2022-11-01 Until 2027-04-01

Purpose

Antiseptic

Description

Ethyl alcohol 62 % v/v


Medication Information

Warnings

Flammable, keep away from fire or flame

For external use only.

Uses
  • For handwashing to decrease bacteria on the skin.
  • Recommended for repeated use.
Purpose

Antiseptic

Directions
  • Wet hands thoroughly with product and allow to dry without wiping.
Other Information

Store at room temperature

Inactive Ingredients

Carbomer, propylene glycol, purified water, titanium dioxide

Description

Ethyl alcohol 62 % v/v

Do Not Use

in the eyes.

Drug Facts

Active Ingredient

Ethyl alcohol 62 % v/v

Stop Use and Ask A Doctor If
  • irritation and redness develop
  • condition persists for more than 72 hours
Keep Out of Reach of Children.

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

Package Labeling: 82996 005 01


Structured Label Content

Warnings

Flammable, keep away from fire or flame

For external use only.

Uses
  • For handwashing to decrease bacteria on the skin.
  • Recommended for repeated use.
Purpose

Antiseptic

Directions
  • Wet hands thoroughly with product and allow to dry without wiping.
Other Information (Other information)

Store at room temperature

Inactive Ingredients (Inactive ingredients)

Carbomer, propylene glycol, purified water, titanium dioxide

Do Not Use (Do not use)

in the eyes.

Drug Facts

Active Ingredient (Active ingredient)

Ethyl alcohol 62 % v/v

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation and redness develop
  • condition persists for more than 72 hours
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Package Labeling: 82996 005 01 (Package Labeling: 82996-005-01)


Advanced Ingredient Data


Raw Label Data

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