PANION AND BF HAND SANITIZER- alcohol gel

PANION AND BF Hand Sanitizer by

Drug Labeling and Warnings

PANION AND BF Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by PANION & BF BIOTECH INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Use

To help decrease bacterial on the skin that could potentially cause disease

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

- In children less than 2 months of age
- On open skin wounds

When using this product keep out of eyes, ears, and mouth, in case of contact with eyes,rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

- Place enough product on hands to cover all surfaces for at least 30 seconds. Then rub hands together until dry.

- Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

- Store between 15-30C (59-86F)

- Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Aqua, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Isononyl Isononanoate, O-Cymen-5-OL, Triethanolamine,Tocopheryl Acetate

SPL UNCLASSIFIED SECTION

USP

Moisturization & Sanitization

30 sec

Dual Action

99.99 % Germs Reduction

PIC/S GMP Manufacturer

Made in Taiwan

Packaging

INGREDIENTS AND APPEARANCE

PANION AND BF HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78279-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78279-001-18	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
2	NDC: 78279-001-49	225 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
3	NDC: 78279-001-99	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
4	NDC: 78279-001-23	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
5	NDC: 78279-001-35	360 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
6	NDC: 78279-001-28	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
7	NDC: 78279-001-30	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020
8	NDC: 78279-001-32	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/30/2020

Labeler - PANION & BF BIOTECH INC. (656381605)

Establishment
Name	Address	ID/FEI	Business Operations
PANION & BF BIOTECH INC.		656381605	manufacture(78279-001)