PROTECT 8- benzalkonium chloride liquid

PROTECT 8 by

Drug Labeling and Warnings

PROTECT 8 by is a Otc medication manufactured, distributed, or labeled by Advanced Hygienics LLC, Wisconsin Pharmacal Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Benzalkonium Chloride 0.13%

PURPOSE

Purpose

Antimicrobial

INDICATIONS & USAGE

Uses

For hand sanitizing to decrease bacteria on the skin.

Recommended for repeated use.

WARNINGS

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 the reach of children.

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

DOSAGE & ADMINISTRATION

Directions

Pump a small amount of foam onto hands.

Rub thoroughly over all surfaces of both hands.

Rub hands together briskly until dry.

INACTIVE INGREDIENT

Inactive ingredients

Water, Polyaminopropyl Biguanide, C8-10 Alkyl Polyglucoside, C12-15 Pareth-7, Dimethicone, Cetrimonium Chloride, Laurtrimonium Chloride, Dihydroxyethyl Cocamine Oxide, Glycereth-17 Cocoate, Citric acid.

PRINCIPAL DISPLAY PANEL

PROTECT 8

Hand

Sanitizer

Alcohol Free

Fragrance Free

Gentle on Skin

16.9 FL OZ (500mL)

container label2

INGREDIENTS AND APPEARANCE

PROTECT 8 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63002-003
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLIHEXANIDE (UNII: 322U039GMF)
CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)
C12-15 PARETH-7 (UNII: 3XY03A79QH)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63002-003-33	9.76 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/15/2017
2	NDC: 63002-003-99	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2017
3	NDC: 63002-003-50	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/15/2017
4	NDC: 63002-003-95	950 mL in 1 BAG; Type 0: Not a Combination Product	01/16/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/15/2017

Labeler - Advanced Hygienics LLC (065359009)

Establishment
Name	Address	ID/FEI	Business Operations
Wisconsin Pharmacal Company		800873986	manufacture(63002-003)