Hand Sanitizer by HUB PEN COMPANY, INC. (HPG Brands) / HUB PEN COMPANY, INC. / BEACON PROMOTIONS, INC. / BEST PROMOTIONS U.S.A., LLC / Handstands Promo

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by HUB PEN COMPANY, INC. (HPG Brands), HUB PEN COMPANY, INC., BEACON PROMOTIONS, INC., BEST PROMOTIONS U.S.A., LLC, Handstands Promo. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- hand sanitizer gel 
HAND SANITIZER- hand sanitizer spray 
HUB PEN COMPANY, INC. (HPG Brands)

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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Ethyl Alcohol 62%

Antiseptic

Warnings

Flammable. keep away from fire or flame.

For external use only

When Using This Product

Keep out of eyes, In case od contact with eyes, rinse with water.

Stop use and ask doctor if irritation nad redness develops and persist.

Keep out of reach of children

If swallowed, get medical help prompltly and contact Poison Control.

Inactive Ingredients

Carbomer, fragrance, Glycerin, propilene glycol, Tocopheryl acetate, Triethanolamine, Water

Directions

Place enough product in your palm to throughly cover your hands and rub hands together until dry.

Children under 6 years should be supervised when using this product.

Uses

Hand sanitizer to help decrease bacteria on the skin

Hand Sanitizer

HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77988-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)	0.027 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.5 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.21 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.2 mL  in 100 mL
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.005 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	36.67 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77988-002-02	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
2	NDC: 77988-002-01	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
3	NDC: 77988-002-03	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/30/2020	06/28/2022

HAND SANITIZER 
hand sanitizer spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77988-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 940 (UNII: 4Q93RCW27E)	0.06 mL  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.5 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.051 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	0.2 mL  in 100 mL
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	0.01 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	37.03 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77988-004-01	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/31/2020	06/30/2022

Labeler - HUB PEN COMPANY, INC. (HPG Brands) (001009000)

Establishment
Name	Address	ID/FEI	Business Operations
HUB PEN COMPANY, INC.		001009000	manufacture(77988-002, 77988-004)

Establishment
Name	Address	ID/FEI	Business Operations
BEACON PROMOTIONS, INC.		136344053	label(77988-002)

Establishment
Name	Address	ID/FEI	Business Operations
BEST PROMOTIONS U.S.A., LLC		932685709	label(77988-002, 77988-004)

Establishment
Name	Address	ID/FEI	Business Operations
Handstands Promo		969743561	label(77988-002, 77988-004)

Revised: 10/2022

Document Id: eb6892ce-177b-c67e-e053-2995a90af1a7

34390-5

Set id: a618a9ab-0e2f-2458-e053-2995a90a275b

Version: 4

Effective Time: 20221019