Blue Gel Hand Sanitizer by Friendo LLC Blue Gel Hand Sanitizer

Blue Gel Hand Sanitizer by

Drug Labeling and Warnings

Blue Gel Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Friendo LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BLUE GEL HAND SANITIZER- isopropyl alcohol gel 
Friendo LLC

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.

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Blue Gel Hand Sanitizer

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

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) consistent with World Health Organization (WHO) recommendations:

1. Isopropyl Alcohol (75.4%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Methacrylic Acid - Ethyl Acrylate Copolymer (4500 MPA.S) (11.5% v/v).
3. Isopropyl Myristate (0.5% v/v).
4. Propylene Glycol (0.5% v/v)
5. Sterile distilled water or boiled cold water.

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

Active Ingredient(s)

Isopropyl Alcohol 75.4% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

Warnings

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

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 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.

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

• 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

Methacrylic Acid - Ethyl Acrylate Copolymer (4500 MPA.S), Isopropyl Myristate, Propylene Glycol, purified water USP

Package Label - Principal Display Panel

2oz (0.059L): 74238-111-01
8oz (0.237L): 74238-111-02
½ Gallon (1.89L): 74238-111-03
4L: 74238-111-04
55 Gallon Drum (208.2L): 74238-111-05
275 Gallon Tote (1,041L): 74238-111-06
330 Gallon Tote (1,249L): 74238-111-07

BLUE GEL HAND SANITIZER 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74238-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	754 mL  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)	115 mL  in 1000 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	5 mL  in 1000 mL
WATER (UNII: 059QF0KO0R)	121 mL  in 1000 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	5 mL  in 1000 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74238-111-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/02/2020	03/30/2022
2	NDC: 74238-111-02	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/02/2020	03/30/2022
3	NDC: 74238-111-03	1890 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/02/2020	03/30/2022
4	NDC: 74238-111-04	4000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/02/2020	03/30/2022
5	NDC: 74238-111-05	208200 mL in 1 DRUM; Type 0: Not a Combination Product	09/02/2020	03/30/2022
6	NDC: 74238-111-06	1041000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	09/02/2020	03/30/2022
7	NDC: 74238-111-07	1249000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	09/02/2020	03/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/02/2020	03/30/2022

Labeler - Friendo LLC (926569711)

Registrant - Friendo LLC (926569711)

Establishment
Name	Address	ID/FEI	Business Operations
Friendo LLC		926569711	manufacture(74238-111)

Revised: 3/2022

Document Id: db7509d3-c69d-88cb-e053-2995a90a0480

34390-5

Set id: ae56432b-2a1e-129a-e053-2995a90abad3

Version: 3

Effective Time: 20220330