80969-020 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- ethyl alcohol gel 
STRONGHOLD TRADING LLC

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80969-020 PFA FOR HAND SANITIZER

Active ingredient

Ethyl Alcohol 70%

Purpose

Antimicrobial

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.

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

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

Package Label

PFA FOR HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80969-020
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
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
MORUS ALBA BARK (UNII: 7O71A48NDP)
CITRUS PARADISI SEED (UNII: 12F08874Y7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80969-020-03	120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/19/2021	03/01/2023
2	NDC: 80969-020-04	250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/19/2021	03/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	11/19/2021	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(80969-020)

Revised: 12/2023

Document Id: 0d64bcbe-af9c-2662-e063-6294a90ac149

34390-5

Set id: d11cac12-91cc-459e-e053-2995a90a7d96

Version: 5

Effective Time: 20231226