Hand Wash: Package Insert and Label Information

HAND WASH- benzalkonium chloride liquid
Harmon Stores, 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.

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Use

for handwashing to decrease bacteria on the skin

warnings

For external use only: hands only

When using this product

  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

  • irritation or redness develops
  • condition persists for more than 72 hours

Keep out of reach of children

if swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • wet hands
  • apply palmful to hands
  • scrub thoroughly
  • rinse thoroughly

Inactive ingredients

water, cocamidopropyl betaine, lauramidopropylamine oxide, lauramine oxide, myristamidopropylamine oxide, glycerin, fragrance, linalool, butylphenyl methylpropional, limonene, geraniol, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, yellow 10, green 3

Distributed by

Harmon Stores, Inc.

650 Liberty Ave

Union, NJ 07083

Visit us at:

www.facevalues.com

principal display panel

REFILL FOR FOAMING HAND WASH DISPENSER

Helps Kill Harmful Germs

HARMON FACEVALUES

Antibacterial FOAMING HAND WASH

Gentle Enough for Daily Use

FRESH PEAR SCENT

32 FL OZ (1 QT) 946 mL

image description
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HAND WASH
benzalkonium chloride liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63940-575
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE .999 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
COCAMIDOPROPYL BETAINE
LAURAMIDOPROPYLAMINE OXIDE
LAURAMINE OXIDE
MYRISTAMIDOPROPYLAMINE OXIDE
GLYCERIN
LINALOOL, (+/-)-
BUTYLPHENYL METHYLPROPIONAL
LIMONENE, (+/-)-
GERANIOL
CITRIC ACID MONOHYDRATE
EDETATE SODIUM
SULISOBENZONE
SODIUM BENZOATE
D&C YELLOW NO. 10
FD&C GREEN NO. 3
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63940-575-45 946 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 03/04/2016
Labeler — Harmon Stores, Inc (804085293)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 088520668 manufacture (63940-575)

Revised: 06/2021 Harmon Stores, Inc

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