NEORELIEF HAND SANITIZER by BioLyte Laboratories, LLC / BioLyte Laboratories LLC

NEORELIEF HAND SANITIZER by

Drug Labeling and Warnings

NEORELIEF HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by BioLyte Laboratories, LLC, BioLyte Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NEORELIEF HAND SANITIZER- neorelief hand sanitizer gel 
BioLyte Laboratories, 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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The hand sanitizer is manufactured using the following ingredients in the preparation of the product:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerin
3. Polyacrylate Crosspolymer-6 (Sepimax Zen).
4. Purified water.

Active Ingredient(s)

Ethyl Alcohol 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic

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

Purified Water, polyacrylate crosspolymer-6 (Sepimax Zen), Glycerin

Package Label - Principal Display Panel

:

NEORELIEF HAND SANITIZER 
neorelief hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58368-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58368-007-01	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/29/2020
2	NDC: 58368-007-02	3785 mL in 1 JUG; Type 0: Not a Combination Product	06/29/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/29/2020

Labeler - BioLyte Laboratories, LLC (015560564)

Establishment
Name	Address	ID/FEI	Business Operations
BioLyte Laboratories LLC		015560564	manufacture(58368-007)

Revised: 11/2022

Document Id: edab70c3-d209-6afb-e053-2a95a90ab51e

34390-5

Set id: b292a376-6a71-0cab-e053-2995a90a639d

Version: 4

Effective Time: 20221117