80969-030-02 PFA FOR HAND SANITIZER

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- benzalkonium chloride 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.

----------

80969-030-02 PFA FOR HAND SANITIZER

Active ingredient

Benzalkonium Chloride 0.066%

Purpose

Disinfectant

Use

Hand sanitizing to help reduce bacteria on the skin.

Warnings

For external use only.

Flammable. Keep away from fire or flame.

When using this product

avoid contact with the eyes.

In case of contact, flush eyes thoroughly with water.

Stop use and ask a doctor if

irritation and redness develops and persists.

Keep out of reach of children.

If swallowed, get medical

help or contact a Poison Control Center immediately.

Directions

• Put enough product in the palm to cover hands & rub together briskly the liquid is dry.
• Children under 6 should be supervised when using Sanitizers.

Other information

• Store below 110°F (43°C)
• May discolor certain fabrics or surfaces.

Inactive ingredients

Water, Glycerin, Carbomer, Triethanolamine, Mentha Piperita (Peppermint) Oil, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Morus Alba Bark Extract, Panthenol

Package Label

PFA FOR HAND SANITIZER 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80969-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.066 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
PEPPERMINT OIL (UNII: AV092KU4JH)
MORUS ALBA BARK (UNII: 7O71A48NDP)
PANTHENOL (UNII: WV9CM0O67Z)
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80969-030-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/03/2021	03/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/03/2021	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(80969-030)

Revised: 3/2023

Document Id: f7d95288-4d7d-4135-e053-6394a90a55cf

34390-5

Set id: c88a8b18-a678-88b1-e053-2a95a90a18dc

Version: 3

Effective Time: 20230326