PREMIUM PROTECTION ANTIBACTERIAL HAND- benzalkonium chloride liquid

Premium Protection Antibacterial Hand by

Drug Labeling and Warnings

Premium Protection Antibacterial Hand by is a Otc medication manufactured, distributed, or labeled by Maintex, Morgan Gallacher Inc DBA Custom Chemical Formulators Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium Chloride......0.13%

Purpose

Antiseptic

Uses

For hand washing to decrease bacteria on the skin.

Warnings

For external use only.

When Using this Product

Avoid contact with the eyes.

In case of eye contact, rinse eyes thoroughly with water.

Do not ingest.

Stop use and contact a doctor if irritation and redness develop

and conditions persist.

Keep out of reach of children.

If swallowed, get medical help

or contact Posion Control Center immediately

Directions

Apply to wet hands. Work into a latther and rinse thoroughly. Children under 6 years of age should be supervised when using this product.

Inactive Ingredients

Water, Cocamidopropyl Betaine, PEG 150 Distearate, Caprylyl Glucoside, Glycerine, Cocamide MIPA, Tetrasodium EDTA, Fragrance, Citric Acid, Aloe Vera, Benzisothiazol, Methylisothiozol, Yellow #5, Red #40

Premium Protection Antibacterial Hand Soap

Premium Protection Antibacterial Hand Soap

INGREDIENTS AND APPEARANCE

PREMIUM PROTECTION ANTIBACTERIAL HAND 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77617-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	13 kg  in 100 kg

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA FLOWER (UNII: 575DY8C1ER)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
FD&C RED NO. 40 (UNII: WZB9127XOA)
EDETATE SODIUM (UNII: MP1J8420LU)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77617-002-02	4 in 1 BOX	04/15/2018
1	NDC: 77617-002-01	3.80564 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M	04/15/2018

Labeler - Maintex (008317307)

Registrant - Maintex (008317307)

Establishment
Name	Address	ID/FEI	Business Operations
Morgan Gallacher Inc DBA Custom Chemical Formulators Inc		028311595	manufacture(77617-002) , api manufacture(77617-002) , pack(77617-002)