SPL v3
SPL
SPL Set ID a646a31f-cb47-173e-e053-2995a90a9f68
Route
TOPICAL
Published
Effective Date 2020-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.3 g)
Inactive Ingredients
Propylene Glycol Phenoxyethanol Didecyldimonium Chloride Water Chlorphenesin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-23

Description

Drug Facts

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Drug Facts

Use

Use for hand-washing to decrease bacteria on the skin when water is not available.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed,get medical help or contact poison control center right away.

Section 50566-9

Stop use and ask a doctor if irritation and redness develop.

Section 50567-7

When using this product ,do not get in eyes.

Warnings

Keep away from fire and flames.For external use only.

Directions

Wet hands thoroughly with product and allow to dry 20-30 seconds.Do not dry or wipe when finished.

Do Not Use

Do not use on open or broken skin.If contact occurs,rinse eyes thoroughly with water.

Other Information

The espiry date is stated on the packaging.Store at -20℃ to+30℃,away from sunlight.

Active Ingredient(s)

Benzalkonium Chloride 0.3%

Inactive Ingredients

Water,Propylene Glycol,DidecyldimoniumChloride ,Phenoxyethanol, Chlorphenesin.

Package Label Principal Display Panel


Structured Label Content

Use

Use for hand-washing to decrease bacteria on the skin when water is not available.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed,get medical help or contact poison control center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation and redness develop.

Section 50567-7 (50567-7)

When using this product ,do not get in eyes.

Purpose

Antiseptic

Warnings

Keep away from fire and flames.For external use only.

Directions

Wet hands thoroughly with product and allow to dry 20-30 seconds.Do not dry or wipe when finished.

Do Not Use (Do not use)

Do not use on open or broken skin.If contact occurs,rinse eyes thoroughly with water.

Other Information (Other information)

The espiry date is stated on the packaging.Store at -20℃ to+30℃,away from sunlight.

Active Ingredient(s)

Benzalkonium Chloride 0.3%

Inactive Ingredients (Inactive ingredients)

Water,Propylene Glycol,DidecyldimoniumChloride ,Phenoxyethanol, Chlorphenesin.

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)