AB 3000 HAND - ANTI-BACTERIAL- benzalkonium chloride liquid

AB 3000 HAND - ANTI-BACTERIAL by

Drug Labeling and Warnings

AB 3000 HAND - ANTI-BACTERIAL by is a Otc medication manufactured, distributed, or labeled by Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Benzalkonium Chloride...........0.13%

Purpose

Antibacterial

Uses

For hand washing to decrease bacteria on the skin.

Warnings

For external use only.

When Using this Product

Avoid contact with eyes. If contat occurs, 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 Poison Control Center immediately.  

Directions

- Apply to wet hands. Work into lather and rinse thoroughly.

- Children under 6 years of age should be supervised when using this product.

INERT 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

AB 3000 HAND - ANTI-BACTERIAL

AB 3000 HAND - ANTI-BACTERIAL

INGREDIENTS AND APPEARANCE

AB 3000 HAND - ANTI-BACTERIAL 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50241-982
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
Water (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL)
GLYCERIN (UNII: PDC6A3C0OX)
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
BENZISOTHIAZOLINONE (UNII: HRA0F1A4R3)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50241-982-02	1 in 1 BOX	10/01/2018
1	NDC: 50241-982-01	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
unapproved drug other		10/01/2018

Labeler - Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. (028311595)

Registrant - Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. (028311595)

Establishment
Name	Address	ID/FEI	Business Operations
Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.		028311595	manufacture(50241-982) , api manufacture(50241-982) , pack(50241-982)