Myterra Food Handler Wash Foam (Benzalkonium Chloride) Soap [Portionpac Chemical Corporation] -

MYTERRA FOOD HANDLER WASH FOAM (BENZALKONIUM CHLORIDE) SOAP [PORTIONPAC CHEMICAL CORPORATION]
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NDC	70780-103-13
Set ID	0fc8dd35-3d01-4a50-9241-d76b7d7a196b
Category	HUMAN OTC DRUG LABEL
Packager	PortionPac Chemical Corporation
Generic Name
Product Class
Product Number
Application Number	PART333E

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Active Ingredient

Benzalkonium Chloride 0.13%
Purpose

Antimicrobial
Use
- For hand washing to decrease bacteria on the skin
- Recommended for repeated use
Warnings

For external use only.

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation or redness develops, or if 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
- Pump a small amount of foam into palm of hand.
- Rub thoroughly over all surfaces of both hands for fifteen seconds.
- Rinse with potable water.
Inactive Ingredients

Water, Coco-Glucoside, Laurtrimonium Chloride, Cocamidopropylamine Oxide, Citric Acid
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MYTERRA FOOD HANDLER WASH FOAM
benzalkonium chloride soap

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
COCO GLUCOSIDE (UNII: ICS790225B)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color	white (water white, dispensed as a white foam)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70780-103-13	8 in 1 BOX	10/30/2017
1		1000 mL in 1 BAG; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	10/30/2017

Labeler - PortionPac Chemical Corporation (005448584)

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Medic