FRESH HANDS- benzalkonium chloride liquid

Fresh Hands by

Drug Labeling and Warnings

Fresh Hands 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.

- 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: 77617-009
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 LEAF (UNII: ZY81Z83H0X)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
MAGNESIUM NITRATE (UNII: 77CBG3UN78)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
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: 77617-009-02	1 in 1 BOX	09/17/2018
1	NDC: 77617-009-01	3.80564 kg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 77617-009-04	1 in 1 BOX	09/17/2018
2	NDC: 77617-009-03	1.01 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	09/16/2018

Labeler - Maintex (008317307)

Registrant - Maintex (008317307)

Establishment
Name	Address	ID/FEI	Business Operations
Morgan Gallacher Inc DBA Custom Chemical Formulators Inc		028311595	manufacture(77617-009) , api manufacture(77617-009) , pack(77617-009)