80593-006

Drug Facts

Composition & Product

Active Ingredients

Benzalkonium (0.13 g)

Inactive Ingredients

Propylene Glycol Aloe Vera Leaf Polysorbate 20 Phenoxyethanol .alpha.-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-03-30

Medication Information

Purpose

Antiseptic

Description

Antiseptic

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease.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 Poison Control Center right away.

Section 50566-9

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

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

Warnings

FOR EXTERNAL USE ONLY.

Do not use

·in children less than 2 months of age

·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 maybe signs of a serious condition.

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

Directions

DIRECTIONS

·Open package.Pull wipe.Close package to retain moisture wet hands thoroughly with product.Allow to dry without rinsing.

·Supervise children under 6 years of age when using this product to avoid swallowing.

Do Not Use

Do not use

·in children less than 2 months of age

·on open skin wounds

Other Information

Store between 15-30C (59-86F)

Avoid freezing and exessive heat aboce 40C (104F)

Inactive Ingredients

INACTIVE INGREDIENTS

Aloe Barbadensis Leaf Juice, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Tocopheryl Acetate, Water

Package Label Principal Display Panel

80593-006-01 10 solution in 1 package

80593-006-02 20 solution in 1 package

80593-006-03 50 solution in 1 package

80593-006-04 80 solution in 1 package

80593-006-05 100 solution in 1 package

80593-006-06 40 solution in 1 canister

80593-006-07 80 solution in 1 canister

80593-006-08 100 solution in 1 canister

80593-006-09 300 solution in 1 canister

80593-006-10 500 solution in 1 canister

Structured Label Content

Use

Hand sanitizer to help reduce bacteria that potentially can cause disease.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 Poison Control Center right away.

Section 50566-9 (50566-9)

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

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

Purpose

Antiseptic

Warnings

FOR EXTERNAL USE ONLY.

Do not use

·in children less than 2 months of age

·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 maybe signs of a serious condition.

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

Directions

DIRECTIONS

·Open package.Pull wipe.Close package to retain moisture wet hands thoroughly with product.Allow to dry without rinsing.

·Supervise children under 6 years of age when using this product to avoid swallowing.

Do Not Use (Do not use)

Do not use

·in children less than 2 months of age

·on open skin wounds

Other Information (Other information)

Store between 15-30C (59-86F)

Avoid freezing and exessive heat aboce 40C (104F)

Inactive Ingredients (Inactive ingredients)

INACTIVE INGREDIENTS

Aloe Barbadensis Leaf Juice, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Tocopheryl Acetate, Water

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

80593-006-01 10 solution in 1 package

80593-006-02 20 solution in 1 package

80593-006-03 50 solution in 1 package

80593-006-04 80 solution in 1 package

80593-006-05 100 solution in 1 package

80593-006-06 40 solution in 1 canister

80593-006-07 80 solution in 1 canister

80593-006-08 100 solution in 1 canister

80593-006-09 300 solution in 1 canister

80593-006-10 500 solution in 1 canister

Advanced Ingredient Data

[{"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZALKONIUM", "unii": "7N6JUD5X6Y", "classCode": "ACTIB", "strengthNumerator": "0.13", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Use": "Hand sanitizer to help reduce bacteria that potentially can cause disease.For use when soap and water are not available.", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation or rash occurs. These maybe signs of a serious condition.", "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 maybe signs of a serious condition. Keep out of reach of children.If swallowed, get medical help or contact Poison Control Center right away.", "Purpose": "Antiseptic", "Warnings": "FOR EXTERNAL USE ONLY. Do not use ·in children less than 2 months of age ·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 maybe signs of a serious condition. Keep out of reach of children.If swallowed, get medical help or contact Poison Control Center right away.", "Directions": "DIRECTIONS ·Open package.Pull wipe.Close package to retain moisture wet hands thoroughly with product.Allow to dry without rinsing. ·Supervise children under 6 years of age when using this product to avoid swallowing.", "Do not use": "Do not use ·in children less than 2 months of age ·on open skin wounds", "Other information": "Store between 15-30C (59-86F) Avoid freezing and exessive heat aboce 40C (104F)", "Inactive ingredients": "INACTIVE INGREDIENTS Aloe Barbadensis Leaf Juice, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Tocopheryl Acetate, Water", "Package Label - Principal Display Panel": "80593-006-01 10 solution in 1 package 80593-006-02 20 solution in 1 package 80593-006-03 50 solution in 1 package 80593-006-04 80 solution in 1 package 80593-006-05 100 solution in 1 package 80593-006-06 40 solution in 1 canister 80593-006-07 80 solution in 1 canister 80593-006-08 100 solution in 1 canister 80593-006-09 300 solution in 1 canister 80593-006-10 500 solution in 1 canister"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information