PFA by BLUE SEA AEROSOL & DAILY CARE CO., LTD PFA- alcohol gel

PFA by

Drug Labeling and Warnings

PFA by is a Otc medication manufactured, distributed, or labeled by BLUE SEA AEROSOL & DAILY CARE CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Ethyl Alcohol 70%(v/v)

Purpose

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

• Put enough product in the palm 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

INGREDIENTS AND APPEARANCE

PFA 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72119-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PEPPERMINT OIL (UNII: AV092KU4JH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CITRUS PARADISI SEED (UNII: 12F08874Y7)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72119-005-02	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/04/2021
2	NDC: 72119-005-01	2 mL in 1 POUCH; Type 0: Not a Combination Product	06/04/2021
3	NDC: 72119-005-03	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/04/2021
4	NDC: 72119-005-04	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/04/2021
5	NDC: 72119-005-05	375 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/04/2021
6	NDC: 72119-005-06	80 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/04/2021
7	NDC: 72119-005-07	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/04/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/04/2021

Labeler - BLUE SEA AEROSOL & DAILY CARE CO., LTD (544373091)

Establishment
Name	Address	ID/FEI	Business Operations
BLUE SEA AEROSOL & DAILY CARE CO., LTD		544373091	manufacture(72119-005)