79866-002

79866-002
SPL v3
SPL
SPL Set ID ab7cab37-3047-3c36-e053-2a95a90a19e1
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.12 g)
Inactive Ingredients
Propylene Glycol Phenoxyethanol Water Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Description

Benzalkonium Chloride 0.12%

Purpose

Antimicroblal


Medication Information

Purpose

Antimicroblal

Description

Benzalkonium Chloride 0.12%

Use

●Hand sanitizer to help reduce bacteria

●For use when soap and water are not available.

Section 50565-1

Keep out of reach of children. If swallowed. get medical help or Contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 50567-7

When using this product do not get in eyes. If

contact is made rinse thoroughly with water.

Warnings

For external use only.

Directions

●Apply to hands, allow to air dry without wiping.

●Children under 6 years of age should be supervised when using this product

Do Not Use

●on children less than 2 months old.

●on open skin wounds

Other Information

●Store in a cool,dry place.

●Avoid freezing and excessive heat.

Active Ingredient(s)

Benzalkonium Chloride 0.12%

Inactive Ingredients

Glycerin, Phenoxyethanol, Propylene Glycol, Purified Water

Package Label Principal Display Panel


Structured Label Content

Use

●Hand sanitizer to help reduce bacteria

●For use when soap and water are not available.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed. get medical help or Contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if irritation or rash appears and lasts.

Section 50567-7 (50567-7)

When using this product do not get in eyes. If

contact is made rinse thoroughly with water.

Purpose

Antimicroblal

Warnings

For external use only.

Directions

●Apply to hands, allow to air dry without wiping.

●Children under 6 years of age should be supervised when using this product

Do Not Use (Do not use)

●on children less than 2 months old.

●on open skin wounds

Other Information (Other information)

●Store in a cool,dry place.

●Avoid freezing and excessive heat.

Active Ingredient(s)

Benzalkonium Chloride 0.12%

Inactive Ingredients (Inactive ingredients)

Glycerin, Phenoxyethanol, Propylene Glycol, Purified Water

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


Advanced Ingredient Data


Raw Label Data

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