DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Alcohol (0.9 mL)

Inactive Ingredients

Trolamine Glycerin Aloe Vera Flower Water Benzoic Acid Carbomer 940 Caprylyl Glycol Decylene Glycol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-04-22

Medication Information

Indications and Usage

To help reduce bacteria on the skin

Description

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) : Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerin Aloe Vera Extract Water Caprylyl Glycol Decylene Glycol Benzoic Acid Carbomer Triethanolamine The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Uses

Antiseptic

Section 42229-5

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) :

Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Glycerin
Aloe Vera Extract
Water
Caprylyl Glycol
Decylene Glycol
Benzoic Acid
Carbomer
Triethanolamine

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Section 50565-1

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if skin irritation or redness develops.

Section 50567-7

When using this product do not use on damaged or broken skin. Do not leave near fire. Wash with enough water, if it gets into eyes. Do not drink

Warnings

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

Directions

Apply enough gel to wet hands and rub together until dry. Use 1 to 3 times a day.

Other Information

Store below 73.4F (23C)

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients

Water, aloe barbadensis (aloe vera extract), triethanolamine, glycerin, caprylyl glycol, decylene glycol, benzoic acid, carbomer

Package Label Principal Display Panel

60 mL NDC: 74949-002-60

250 mL NDC: 74949-002-25

495 mL NDC: 74949-002-49

20000 mL NDC: 74949-002-20

Structured Label Content

Uses

Antiseptic

Indications and Usage (34067-9)

To help reduce bacteria on the skin

Section 42229-5 (42229-5)

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) :

Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Glycerin
Aloe Vera Extract
Water
Caprylyl Glycol
Decylene Glycol
Benzoic Acid
Carbomer
Triethanolamine

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if skin irritation or redness develops.

Section 50567-7 (50567-7)

When using this product do not use on damaged or broken skin. Do not leave near fire. Wash with enough water, if it gets into eyes. Do not drink

Warnings

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

Directions

Apply enough gel to wet hands and rub together until dry. Use 1 to 3 times a day.

Other Information (Other information)

Store below 73.4F (23C)

Active Ingredient(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

Water, aloe barbadensis (aloe vera extract), triethanolamine, glycerin, caprylyl glycol, decylene glycol, benzoic acid, carbomer

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

60 mL NDC: 74949-002-60

250 mL NDC: 74949-002-25

495 mL NDC: 74949-002-49

20000 mL NDC: 74949-002-20

Advanced Ingredient Data

[{"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "0.9", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ALOE VERA FLOWER", "unii": "575DY8C1ER", "classCode": "IACT", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "25", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "BENZOIC ACID", "unii": "8SKN0B0MIM", "classCode": "IACT", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CARBOMER 940", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "0.5", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CAPRYLYL GLYCOL", "unii": "00YIU5438U", "classCode": "IACT", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "DECYLENE GLYCOL", "unii": "S57M60MI88", "classCode": "IACT", "strengthNumerator": "0.1", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Antiseptic", "34067-9": "To help reduce bacteria on the skin", "42229-5": "The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) : Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20. Glycerin Aloe Vera Extract Water Caprylyl Glycol Decylene Glycol Benzoic Acid Carbomer Triethanolamine The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.", "50565-1": "Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if skin irritation or redness develops.", "50567-7": "When using this product do not use on damaged or broken skin. Do not leave near fire. Wash with enough water, if it gets into eyes. Do not drink", "Warnings": "For external use only. Flammable. Keep away from fire or flame", "Directions": "Apply enough gel to wet hands and rub together until dry. Use 1 to 3 times a day.", "Other information": "Store below 73.4F (23C)", "Active Ingredient(s)": "Ethyl Alcohol 70% v/v. Purpose: Antiseptic", "Inactive ingredients": "Water, aloe barbadensis (aloe vera extract), triethanolamine, glycerin, caprylyl glycol, decylene glycol, benzoic acid, carbomer", "Package Label - Principal Display Panel": "60 mL NDC: 74949-002-60 250 mL NDC: 74949-002-25 495 mL NDC: 74949-002-49 20000 mL NDC: 74949-002-20"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information