PFA by Zhejiang Guoyao Jingyue Aerosol Co., Ltd. PFA- ethyl alcohol gel

PFA by

Drug Labeling and Warnings

PFA by is a Otc medication manufactured, distributed, or labeled by Zhejiang Guoyao Jingyue Aerosol Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 70% v/v.

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

When using this product avoid contact with the eyes. In case of contact, flush eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation and redness develops or 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

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

Other information

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

Inactive ingredients

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

Package Label - Principal Display Panel

60 mL/2 fl.oz

INGREDIENTS AND APPEARANCE

PFA 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75742-008
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
CITRUS PARADISI SEED (UNII: 12F08874Y7)
MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75742-008-01	2 mL in 1 POUCH; Type 0: Not a Combination Product	03/02/2021
2	NDC: 75742-008-02	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/02/2021
3	NDC: 75742-008-03	375 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/02/2021
4	NDC: 75742-008-04	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/02/2021
5	NDC: 75742-008-05	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/02/2021
6	NDC: 75742-008-06	80 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/02/2021
7	NDC: 75742-008-07	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/02/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/02/2021

Labeler - Zhejiang Guoyao Jingyue Aerosol Co., Ltd. (554529812)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Guoyao Jingyue Aerosol Co., Ltd.		554529812	manufacture(75742-008)