PF ANTI-BACTERIAL HAND SANITIZING WIPES- benzalkonium chloride liquid
Premium Formulations LLC

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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PF Anti-Bacterial Hand Sanitizing Wipes

Active Ingredient

Benzalkonium Chloride 0.12 Percent

Purpose

Antiseptic

Uses

For hand washing to decrease bacteria on the skin.

Warnings

For external use only.

Do not use in the eyes.

Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

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

Directions

Open label, remove one wipe, and unfold.

Wet hands thoroughly with product and allow to dry without wiping.

Other information

Store below 95 degree Fahrenheit (35 degree Celsius)

May discolor certain fabrics or surfaces.

Inactive ingredients

Aloe barbadensis, Cetylpyridinium Chloride, Citric Acid, Disodium Cocoamphodiacetate, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium Citrate, Tetrasodium EDTA, Water.

Other Information

Manufactured in China by

ISO9001 accredited facility for

Premium Formulations LLC,

Newark, DE 19711, USA

PF 1 Wipe

Premium Formulations

ANTI-BACTERIAL HAND SANITIZING WIPES

KILLS 99.9 percent OF GERMS

PF ANTI-BACTERIAL HAND SANITIZING WIPES
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76323-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.12 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
EDETATE SODIUM (UNII: MP1J8420LU)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:76323-001-00	4.7 g in 1 PACKAGE; Type 0: Not a Combination Product	07/01/2011	07/01/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/01/2011	07/01/2011

Labeler - Premium Formulations LLC (831281097)

Registrant - American Hygienics Corporation (545198454)

Name	Address	ID/FEI	Business Operations
Establishment
American Hygienics Corporation		545198454	manufacture(76323-001)

Revised: 11/2016

Document Id: 40418ac5-9891-0f9a-e054-00144ff88e88

Set id: b5e1321a-8587-4e98-ae66-17ad0c4231d5

Version: 2

Effective Time: 20161101

Premium Formulations LLC