POET Gel Hand Sanitizer by POET Research Center, LLC

POET Gel Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

POET GEL HAND SANITIZER- gel hand sanitizer gel 
POET Research Center, 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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Active ingredient: Alcohol 70% v/v

Purpose: Antiseptic

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 or 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.

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.

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

Inactive ingredients: glycerin, isopropyl alcohol, PEG 6 & acrylates/vinyl crosspolymer, water

Gel - A semisolid dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion. A gel may contain suspended particles.

POET Gel Hand Sanitizer Label

POET Gel Hand Sanitizer,

Ethanol 70% v/v

Topical Gel Solution

Non-sterile Solution

Manufactured By:

POET

851 Washington St,

Scotland, SD 57059

Drug Facts

Active ingredient[s] Purpose

Alcohol 70% v/v....................................................................................................................................................... Antiseptic

Use[s]

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.

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 glycerin, isopropyl alcohol, PEG 6 & acrylates/vinyl crosspolymer, water

POET GEL HAND SANITIZER 
gel hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75402-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75402-003-01	59.1471 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/12/2020	11/01/2021
2	NDC: 75402-003-02	236.588 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/12/2020	07/31/2021
3	NDC: 75402-003-03	3785.41 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/12/2020	07/31/2021
4	NDC: 75402-003-04	473.176 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/12/2020	11/01/2021
5	NDC: 75402-003-05	946.353 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/12/2020	07/31/2021
6	NDC: 75402-003-06	39.97 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/05/2020	07/31/2021
7	NDC: 75402-003-07	208198 mL in 1 DRUM; Type 0: Not a Combination Product	10/05/2020	07/31/2021
8	NDC: 75402-003-08	946353 mL in 1 CONTAINER; Type 0: Not a Combination Product	10/05/2020	07/31/2021
9	NDC: 75402-003-09	2 mL in 1 CONTAINER; Type 0: Not a Combination Product	05/01/2021	07/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/05/2020	11/01/2021

Labeler - POET Research Center, LLC (189046659)

Establishment
Name	Address	ID/FEI	Business Operations
POET Research Center, LLC		189046659	manufacture(75402-003)

Revised: 11/2021

Document Id: d072b380-b3dd-4ac6-e053-2995a90a7b63

34390-5

Set id: adcde28b-560e-c68e-e053-2995a90abcc1

Version: 10

Effective Time: 20211110