Hand Sanitizer by HUB PEN COMPANY, INC.

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by HUB PEN COMPANY, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- hand sanitizer spray 
HUB PEN COMPANY, INC.

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

Ethyl Alcohol 75%

Purpose

Antiseptic

Uses

Hand sanitizer to help bacteria on skin.

Warnings

Flammable. Keep away from heat and flame.

For external use only.

When using this product

Keep out of eyes.

In case of cotact with eyes, flush througly with water.

Avoid contact with broken skin.

do not inhale or ingest.

Stop use and ask a doctor

If irritation and redness develops and persists for more than 72 hours.

Inactive Ingredients

carbomer, Glycerine, Thrietanolamine, Water.

Keep out of reach of children

If swallowed, get medical help or call a Poison Control Center right away.

Directions

Wet hands throughly with product, briskly rub together until dry.

Always supervid=se children in the use of this product.

Children under age of 6 months: asl a doctor.

PDP panel

Hand Snitizer

5ml 017 fl oz

NDC: 77988-003-01

HAND SANITIZER 
hand sanitizer spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77988-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)	0.5 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	20.5 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	4 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77988-003-01	5 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/15/2020	06/30/2022

Labeler - HUB PEN COMPANY, INC. (001009000)

Establishment
Name	Address	ID/FEI	Business Operations
HUB PEN COMPANY, INC.		001009000	manufacture(77988-003)

Revised: 10/2022

Document Id: eb689f47-ef38-18c0-e053-2a95a90aad87

34390-5

Set id: ab108618-5059-d27c-e053-2995a90a9a76

Version: 3

Effective Time: 20221019