Antiseptic Gel Hand Rub

Antiseptic Gel Hand Rub
SPL v4
SPL
SPL Set ID 61dbc28c-6011-44a8-983d-0f6f2fe8d762
Route
TOPICAL
Published
Effective Date 2019-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (620 mg)
Inactive Ingredients
Water Ppg-20 Methyl Glucose Ether Diisopropanolamine Lemon Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-01

Description

Alcohol denat. (anhydrous) 62%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol denat. (anhydrous) 62%

Use

Instant hand antiseptic

Warnings

Keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water. For external use only.

Keep away from fire or flame. Flammable.

Directions
  • Apply to clean, dry hands
  • Wet hands thoroughly with product and allow to dry
Active Ingredient

Alcohol denat. (anhydrous) 62%

Other Information
  • Recommended for repeated use 
  • Reduces bacteria that can potentially cause disease
Package Labeling:

Inactive Ingredients

Purified water, Carbomer 2020, PPG-20 methyl glucose ether, Carbomer 980, Diisopropanolamine, Fragrance (Lemon), FD&C blue No.1, FD&C yellow No.5 

Stop Use and Ask A Doctor

if significant irritation or sensitization occurs.

Keep Out of Reach of Children.

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.


Structured Label Content

Use

Instant hand antiseptic

Purpose

Antiseptic

Warnings

Keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water. For external use only.

Keep away from fire or flame. Flammable.

Directions
  • Apply to clean, dry hands
  • Wet hands thoroughly with product and allow to dry
Active Ingredient (Active ingredient)

Alcohol denat. (anhydrous) 62%

Other Information (Other information)
  • Recommended for repeated use 
  • Reduces bacteria that can potentially cause disease
Package Labeling:

Inactive Ingredients (Inactive ingredients)

Purified water, Carbomer 2020, PPG-20 methyl glucose ether, Carbomer 980, Diisopropanolamine, Fragrance (Lemon), FD&C blue No.1, FD&C yellow No.5 

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

if significant irritation or sensitization occurs.

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

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.


Advanced Ingredient Data


Raw Label Data

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