SPL v1
SPL
SPL Set ID 4855806d-6959-72ee-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2013-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.0013 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-01-20

Description

Benzalkonium Chloride  0.13%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Benzalkonium Chloride  0.13%

Use

Prevent infection in minor scrapes

Section 50565-1

Keep out of reach of children.if swallowed get medical help or contact Poison control Center right away.

Section 51945-4

Warnings

For external use only

Flammable,keep away for fire or flame

Do not use:

* In large quantities

* over large areas of the body

* in eyes

* over raw or blistered areas

Stop use and ask a doctor if conditions worsen or persist for more than 7 days or clear up and occur again within a few days.

Directions

Adults and Children 2 year and older; Apply to cleaned affected area not more than 3 times daily.

Children under 2 years of age ; Consult a doctor

Active Ingredients

Benzalkonium Chloride  0.13%

Inactive Ingredient

Purified Water


Structured Label Content

Use

Prevent infection in minor scrapes

Section 50565-1 (50565-1)

Keep out of reach of children.if swallowed get medical help or contact Poison control Center right away.

Section 51945-4 (51945-4)

Purpose

Antiseptic

Warnings

For external use only

Flammable,keep away for fire or flame

Do not use:

* In large quantities

* over large areas of the body

* in eyes

* over raw or blistered areas

Stop use and ask a doctor if conditions worsen or persist for more than 7 days or clear up and occur again within a few days.

Directions

Adults and Children 2 year and older; Apply to cleaned affected area not more than 3 times daily.

Children under 2 years of age ; Consult a doctor

Active Ingredients

Benzalkonium Chloride  0.13%

Inactive Ingredient

Purified Water


Advanced Ingredient Data


Raw Label Data

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