b34bf1e7-ac8f-dcb0-e053-2995a90ae55a

Drug Facts

Composition & Product

Active Ingredients

isopropyl alcohol (75 mL)

Inactive Ingredients

carbomer homopolymer, unspecified type propylene glycol glycerin hydrogen peroxide water aloe arborescens leaf isopropyl myristate .alpha.-tocopherol acetate, d-

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-11-04

Medication Information

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Water, Hydrogen Peroxide, Glycerin, Carbomer and/or Crosspolymers, Isopropyl Myristate 0% to < 0.25%, Propylene Glycol, Aloe Arborescens Leaf and/or Tocopheryl Acetate, Fragrance.

Description

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. The hand sanitizer is manufactured using only the following ingredients in the preparation of the product: Isopropyl Alcohol (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Sterile distilled water or boiled cold water. Hydrogen Peroxide Glycerin Isopropyl Myristate 0% to < 0.25% Propylene Glycol Carbomer and/or acrylates/alkyl polymers Aloe Arborescens Leaf Tocopheryl Acetate Fragrance

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 42229-5

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

The hand sanitizer is manufactured using only the following ingredients in the preparation of the product:

Isopropyl Alcohol (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

Sterile distilled water or boiled cold water.

Hydrogen Peroxide

Glycerin

Isopropyl Myristate 0% to < 0.25%

Propylene Glycol

Carbomer and/or acrylates/alkyl polymers

Aloe Arborescens Leaf

Tocopheryl Acetate

Fragrance

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.

Do Not Use

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

Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Package Label Principal Display Panel

208 L NDC: 74988-735-55

Structured Label Content

Warnings

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

Purpose

Antiseptic, Hand Sanitizer

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information (Other information)

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients (Inactive ingredients)

Water, Hydrogen Peroxide, Glycerin, Carbomer and/or Crosspolymers, Isopropyl Myristate 0% to < 0.25%, Propylene Glycol, Aloe Arborescens Leaf and/or Tocopheryl Acetate, Fragrance.

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Section 42229-5 (42229-5)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

The hand sanitizer is manufactured using only the following ingredients in the preparation of the product:

Isopropyl Alcohol (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

Sterile distilled water or boiled cold water.

Hydrogen Peroxide

Glycerin

Isopropyl Myristate 0% to < 0.25%

Propylene Glycol

Carbomer and/or acrylates/alkyl polymers

Aloe Arborescens Leaf

Tocopheryl Acetate

Fragrance

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.

Do Not Use (Do not use)

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

Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

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

208 L NDC: 74988-735-55

Advanced Ingredient Data

[{"name": "CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "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": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "ACTIB", "strengthNumerator": "75", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ALOE ARBORESCENS LEAF", "unii": "09TD8L5SQV", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE, D-", "unii": "A7E6112E4N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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.", "42229-5": "Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. The hand sanitizer is manufactured using only the following ingredients in the preparation of the product: Isopropyl Alcohol (75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Sterile distilled water or boiled cold water. Hydrogen Peroxide Glycerin Isopropyl Myristate 0% to < 0.25% Propylene Glycol Carbomer and/or acrylates/alkyl polymers Aloe Arborescens Leaf Tocopheryl Acetate Fragrance", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if irritation or rash occurs. These may be 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 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": "Antiseptic, Hand Sanitizer", "Warnings": "For external use only. Flammable. Keep away from heat or flame", "Directions": "Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.", "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 excessive heat above 40C (104F)", "Active Ingredient(s)": "Isopropyl Alcohol 75% v/v. Purpose: Antiseptic", "Inactive ingredients": "Water, Hydrogen Peroxide, Glycerin, Carbomer and/or Crosspolymers, Isopropyl Myristate 0% to < 0.25%, Propylene Glycol, Aloe Arborescens Leaf and/or Tocopheryl Acetate, Fragrance.", "Package Label - Principal Display Panel": "208 L NDC: 74988-735-55"}