SPL v4
SPL
SPL Set ID 86885bfb-579e-4fdd-90f0-53c7bbdbb781
Route
TOPICAL
Published
Effective Date 2020-04-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Glycerin Propylene Glycol Water Aminomethylpropanol Carbomer Homopolymer Type C

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-13

Description

Alcohol 75% v/v.

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Alcohol 75% v/v.

Usage

To decrease bacteria on skin that could cause disease  Recommended for repeated use

Use anywhere without water

Section 50565-1

- Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Warnings

For external use only-hands



- Flammable. Keep away from heat and flame.

- Discontinue if skin becomes irritated and ask a doctor.



Directions

Wet hands thoroughly with product and rub until dry without wiping.

For children under 6, use only with adult supervision.

Not recommended for infants.

Active Ingredient

Alcohol 75% v/v.

Inactive Ingredients

Aqua (water), Glycerin, Propylene glycol, Alcohol, Carbomer, Aminomethly Propanol, Parfume

Package Label 59 Ml & 236 Ml

59 mL label front

59 mL labe back

Label 236 mL 


Structured Label Content

Usage

To decrease bacteria on skin that could cause disease  Recommended for repeated use

Use anywhere without water

Section 50565-1 (50565-1)

- Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Purpose

Antiseptic

Warnings

For external use only-hands



- Flammable. Keep away from heat and flame.

- Discontinue if skin becomes irritated and ask a doctor.



Directions

Wet hands thoroughly with product and rub until dry without wiping.

For children under 6, use only with adult supervision.

Not recommended for infants.

Active Ingredient

Alcohol 75% v/v.

Inactive Ingredients (Inactive ingredients)

Aqua (water), Glycerin, Propylene glycol, Alcohol, Carbomer, Aminomethly Propanol, Parfume

Package Label 59 Ml & 236 Ml (Package Label - 59 mL & 236 mL)

59 mL label front

59 mL labe back

Label 236 mL 


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)