PANION AND BF HAND SANITIZER- alcohol gel 
PANION & BF BIOTECH INC.

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.

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PANION & BF® Hand Sanitizer Gel

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

USP

Moisturization & Sanitization

30 sec

Dual Action

99.99 % Germs Reduction

PIC/S GMP Manufacturer

Made in Taiwan

Packaging

IMAGE

PANION AND BF HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78279-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78279-001-18120 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
2NDC:78279-001-49225 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
3NDC:78279-001-99240 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
4NDC:78279-001-23300 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
5NDC:78279-001-35360 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
6NDC:78279-001-28500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
7NDC:78279-001-301000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
8NDC:78279-001-323785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/30/2020
Labeler - PANION & BF BIOTECH INC. (656381605)
Establishment
NameAddressID/FEIBusiness Operations
PANION & BF BIOTECH INC.656381605manufacture(78279-001)

Revised: 7/2020
Document Id: 99df0467-0f6f-4128-a592-0ad4efd9c5aa
Set id: de592bae-c154-4264-b8ab-8b07ce5e06f7
Version: 1
Effective Time: 20200701
 
PANION & BF BIOTECH INC.