43116-010

43116-010
SPL v2
SPL
SPL Set ID aba82435-00cd-6018-e053-2a95a90aa5fb
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 g)
Inactive Ingredients
Fragrance Lemon Orc2001060 Glycerin Phenoxyethanol Water Aloe Vera Leaf

Identifiers & Packaging

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

Description

Benzalkonium chloride 0.1%

Purpose

Antibacterial


Medication Information

Purpose

Antibacterial

Description

Benzalkonium chloride 0.1%

Use

Use decrease bacteria on skin

Section 50565-1

Keep out of reach of children

If swallowed, seek medical attention or contact a poison control center right away.

Section 50566-9

/

Section 50567-7

When using this product do not get into eyes. If contact occurs, rinse thoroughly with water

Warnings

Warnings for external use only.

Directions

For adults and children of 3 years and over, use on hands to clean and refresh, allow skin to air dry

For children under 3 years of age, consult with a doctor before use

Do Not Use

Do not use over large areas of the body if you are allergic to any of the ingredients.

Other Information

/

Active Ingredient(s)

Benzalkonium chloride 0.1%

Inactive Ingredients

Water, Phenoxyethanol, Aloe Barbadensis Leaf Extract, Glycerin, Fragrance

Package Label Principal Display Panel


Structured Label Content

Use

Use decrease bacteria on skin

Section 50565-1 (50565-1)

Keep out of reach of children

If swallowed, seek medical attention or contact a poison control center right away.

Section 50566-9 (50566-9)

/

Section 50567-7 (50567-7)

When using this product do not get into eyes. If contact occurs, rinse thoroughly with water

Purpose

Antibacterial

Warnings

Warnings for external use only.

Directions

For adults and children of 3 years and over, use on hands to clean and refresh, allow skin to air dry

For children under 3 years of age, consult with a doctor before use

Do Not Use (Do not use)

Do not use over large areas of the body if you are allergic to any of the ingredients.

Other Information (Other information)

/

Active Ingredient(s)

Benzalkonium chloride 0.1%

Inactive Ingredients (Inactive ingredients)

Water, Phenoxyethanol, Aloe Barbadensis Leaf Extract, Glycerin, Fragrance

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


Advanced Ingredient Data


Raw Label Data

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