PFA FOR HAND SANITIZER by STRONGHOLD TRADING LLC / S-ONE PHARMACEUTICAL INC 80969-010

PFA FOR HAND SANITIZER by

Drug Labeling and Warnings

PFA FOR HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by STRONGHOLD TRADING LLC, S-ONE PHARMACEUTICAL INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PFA FOR HAND SANITIZER- ethyl alcohol gel 
STRONGHOLD TRADING 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.

----------

80969-010

Active Ingredient

Erthyl alcohol 70%

Purpose

Antimicrobial

Uses

Hand sanitizer to help reduce bacteria on the skin.

Warnings

Flammable. Keep away from fire or flame.

For external use only.

When using this product

do not use in or near the eyes.

In case of contact, rinse eyes throughly with water.

Stop use and ask a doctor

irritation or rash appears and lasts.

Keep out of reach of children.

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

Directoins

Put enough product in your palm to cover hands and rub hands together briskly until dry.

Children under 6 years of age should be supervised when using Safe Cleaner Plus Hand Sanitizer Gel.

Other information

Store below 110ºF (43ºC)

May discolor certain fabrics or surfaces.

Inactive Ingredients

Glycerine, Ethanol, Purified water, Propylene glycol, Carbomer, Triethanolamine, Sophora extract, Grapefruit seed extract, Mentha Oil

Package Label

PFA FOR HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80969-010
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
PEPPERMINT OIL (UNII: AV092KU4JH)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
CITRUS PARADISI SEED (UNII: 12F08874Y7)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80969-010-01	2 mL in 1 POUCH; Type 0: Not a Combination Product	11/19/2020	03/01/2023
2	NDC: 80969-010-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/19/2020	03/01/2023
3	NDC: 80969-010-06	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/19/2020	03/01/2023
4	NDC: 80969-010-07	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/19/2020	03/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/19/2020	03/01/2023

Labeler - STRONGHOLD TRADING LLC (117694134)

Registrant - S-ONE PHARMACEUTICAL INC (694626932)

Establishment
Name	Address	ID/FEI	Business Operations
S-ONE PHARMACEUTICAL INC		694626932	manufacture(80969-010)

Revised: 3/2023

Document Id: f7d92e52-792f-5557-e053-6294a90aca91

34390-5

Set id: b46f8319-27cb-66ec-e053-2a95a90a272e

Version: 4

Effective Time: 20230326