SPL v3
SPL
SPL Set ID 1a0af5db-3c5d-4c8d-9fdb-6b3dfd5786e3
Route
TOPICAL
Published
Effective Date 2020-04-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (68 mL)
Inactive Ingredients
Glycerin Sodium Hydroxide Water Carbomer 940 Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-04-09

Description

Drug Fact

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Drug Fact

Use

To decrease the bacteria on the skin that could cause disease

Recommended for repeated use

Section 42229-5

Drug Fact

Section 50565-1

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

Section 50567-7

Keep out of eyes. In case of contact with eyes, flush thoroughly with water

Do not inhale or ingest

Avoid contact with broken skin

Warnings

For external use only.

Flammable. Keep away from heat and flame

Discontinue if skin becomes irritated and ask a doctor

Directions

Wet hands thoroughly with products and rub untill dry withour wiping

For children under 6, use only under adult supervision

Not recommended for infants

Other Information

Do not store above 105F

May discolor some fabrics

Harmful to wooden finishes and plastics

Active Ingredient(s)

Ethyl Alcohol 68%

Inactive Ingredients

Water, glycerin, propylene glycol, carbomer, sodium hydroxide

Package Label Principal Display Panel


Structured Label Content

Use

To decrease the bacteria on the skin that could cause disease

Recommended for repeated use

Section 42229-5 (42229-5)

Drug Fact

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

Keep out of eyes. In case of contact with eyes, flush thoroughly with water

Do not inhale or ingest

Avoid contact with broken skin

Purpose

Antiseptic

Warnings

For external use only.

Flammable. Keep away from heat and flame

Discontinue if skin becomes irritated and ask a doctor

Directions

Wet hands thoroughly with products and rub untill dry withour wiping

For children under 6, use only under adult supervision

Not recommended for infants

Other Information (Other information)

Do not store above 105F

May discolor some fabrics

Harmful to wooden finishes and plastics

Active Ingredient(s)

Ethyl Alcohol 68%

Inactive Ingredients (Inactive ingredients)

Water, glycerin, propylene glycol, carbomer, sodium hydroxide

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)