Alcohol-based Disinfectant Hand Sanitizer Gel

Drug Facts

Composition & Product

Active Ingredients

Alcohol (75 mL)

Inactive Ingredients

Carbomer Interpolymer Type A (55000 Cps) Trolamine Glycerin Hydrogen Peroxide Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-03-20

Medication Information

Purpose

Antimicrobial

Description

Ethyl Alcohol 75%

Use

• Place enough Product in your palm to thoroughly spread on both hands and rubinto the skin until dry.

• Children under 6 years of age should be supervised when using this product see full prescribing information for label

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

• In children less than 2 months of age

• On open wounds

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. Flammable. Keep away from heat or flame

Directions

When using this product, do not use in

or near the eyes. In case of contact, rinse

eyes thoroughly with water. Stop using

and ask doctor if irritation or rash appears

and lasts. Keep out of reach of children.

If swollowed, get medical help or contact a

Poison Control Center immediately.

Do Not Use

in children less than 2 months of age
on open skin wounds

Other Information

Other Information:

• Store below 106° F (41° C)

• May discolor certain fabrics or surfaces.

Active Ingredient(s)

Ethyl Alcohol 75%

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label Principal Display Panel

Structured Label Content

Use (USE)

• Place enough Product in your palm to thoroughly spread on both hands and rubinto the skin until dry.

• Children under 6 years of age should be supervised when using this product see full prescribing information for label

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)

• In children less than 2 months of age

• On open wounds

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.

Purpose

Antimicrobial

Warnings

For external use only. Flammable. Keep away from heat or flame

Directions

When using this product, do not use in

or near the eyes. In case of contact, rinse

eyes thoroughly with water. Stop using

and ask doctor if irritation or rash appears

and lasts. Keep out of reach of children.

If swollowed, get medical help or contact a

Poison Control Center immediately.

Do Not Use (Do not use)

in children less than 2 months of age
on open skin wounds

Other Information (Other information)

Other Information:

• Store below 106° F (41° C)

• May discolor certain fabrics or surfaces.

Active Ingredient(s)

Ethyl Alcohol 75%

Inactive Ingredients (Inactive ingredients)

glycerin, hydrogen peroxide, purified water USP

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

Advanced Ingredient Data

[{"name": "CARBOMER INTERPOLYMER TYPE A (55000 CPS)", "unii": "59TL3WG5CO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"USE": "• Place enough Product in your palm to thoroughly spread on both hands and rubinto the skin until dry. • Children under 6 years of age should be supervised when using this product see full prescribing information for label", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "• In children less than 2 months of age • On open wounds", "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.", "Purpose": "Antimicrobial", "Warnings": "For external use only. Flammable. Keep away from heat or flame", "Directions": "When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water. Stop using and ask doctor if irritation or rash appears and lasts. Keep out of reach of children. If swollowed, get medical help or contact a Poison Control Center immediately.", "Do not use": "in children less than 2 months of age on open skin wounds", "Other information": "Other Information: • Store below 106° F (41° C) • May discolor certain fabrics or surfaces.", "Active Ingredient(s)": "Ethyl Alcohol 75%", "Inactive ingredients": "glycerin, hydrogen peroxide, purified water USP"}

Alcohol-based Disinfectant Hand Sanitizer Gel

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information