79866-008

79866-008
SPL v2
SPL
SPL Set ID af6589f9-3b0b-7548-e053-2995a90a4ddf
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.13 g)
Inactive Ingredients
Fragrance Clean Orc0600327 Propylene Glycol Water Alpha-tocopherol Glycerin Phenoxyethanol Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-09-16

Description

Benzalkonium Chloride 0.13%


Medication Information

Description

Benzalkonium Chloride 0.13%

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 occurs. These may be signs of a serious condition

Section 50567-7

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

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

Warnings

For external use only.

Do not use

●in children less than 2 months old.

●on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

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

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

●in 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 0.13%

Inactive Ingredients

Aloe Barbadensis Extract, Alpha-Tocopherol, Fragrance, 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 occurs. These may be signs of a serious condition

Section 50567-7 (50567-7)

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

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

Warnings

For external use only.

Do not use

●in children less than 2 months old.

●on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition

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

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)

●in 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 0.13%

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Extract, Alpha-Tocopherol, Fragrance, 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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