FRESH HANDS- benzalkonium chloride liquid

Fresh Hands by

Drug Labeling and Warnings

Fresh Hands 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

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.

- If contact occurs, rinse eyes thorougly with water. Do not ingest.

- Stop use and contact a doctor if irritation or redness develop

  and conditions persist.

Keep out of reach of children.

Keep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center immediately.

Directions

-Apply to wet hands, work into a lather and rinse thoroughly.

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

Inactive Ingredients

Water, Cocamidopropyl Betaine, Caprylyl Glucoside, Glycerine, Tetrasodium EDTA, Benzisothiazol, Methylisothiozol, Fragrance, Citric Acid, Aloe Vera, Yellow #5, Red #40.

Fresh Hands

Fresh Hands

INGREDIENTS AND APPEARANCE

FRESH HANDS 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50241-990
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)
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: 50241-990-02	1 in 1 BOX	09/17/2018
1	NDC: 50241-990-01	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		09/16/2018

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(50241-990) , api manufacture(50241-990) , pack(50241-990)