GOURMET KITCHEN REGENERATING ANTI-BACTERIAL FRESH PICKED FIG- benzalkonium chloride lotion GOURMET KITCHEN REGENERATING ANTI-BACTERIAL SWEET PLUM- benzalkonium chloride lotion

Gourmet Kitchen Regenerating Anti-Bacterial by

Drug Labeling and Warnings

Gourmet Kitchen Regenerating Anti-Bacterial by is a Otc medication manufactured, distributed, or labeled by GANZ U.S.A., LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzalkonium Chloride 0.1%

Purpose

Antiseptic

Uses

To decrease bacteria on hands.

Warnings

For external use only.

When using this product

• Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
• Avoid contact with broken skin.
• Do not inhale or ingest.

Stop use and ask a doctor if skin irritation develops.

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact Poison Control Center immediately.

Directions

• Apply to hands thoroughly. Use daily or when needed to restore moisture and to decrease bacteria on skin.

Other information

• Do not store above 105°F.
• May discolor some fabrics.
• Harmful to wood finishes and plastics.
• You may report a serious adverse reaction to this product to: Ganz U.S.A., LLC #043, 60 Industrial Parkway, Cheektowaga, New York, 14227-9903

Inactive ingredients

Aqua (Water), Glycerin, Cetyl Alcohol, Glyceryl Stearate, Cetearyl Alcohol, Ceteareth-20, Dimethicone, Stearic Acid, Parfum (Fragrance), Althaea Officinalis Extract, Milk Lipid, Mangifera Indica (Mango) Seed Butter, Butyrospermum Parkii (Shea Butter), Ethylhexyl Palmitate, Petrolatum, Polyethylene, Tocopheryl Acetate, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Carbomer, Sodium Hydroxide, Tetrasodium EDTA, Ultramarines. CONTAINS: Milk and Shea

PRINCIPAL DISPLAY PANEL - 255 mL Bottle Label

time & again®

REGENERATING
ANTI-BACTERIAL
hand cream

fresh picked fig

FORMULATED WITHOUT:
PARABENS, FORMALDEHYDE
RELEASING PRESERVATIVES

CLEAN
FORMULA

8.6 fl oz (255 mL)

PRINCIPAL DISPLAY PANEL - 255 mL Bottle Label

time & again®

REGENERATING
ANTI-BACTERIAL
hand cream

sweet wild plum

FORMULATED WITHOUT:
PARABENS, FORMALDEHYDE
RELEASING PRESERVATIVES

CLEAN
FORMULA

8.6 fl oz (255 mL)

INGREDIENTS AND APPEARANCE

GOURMET KITCHEN REGENERATING ANTI-BACTERIAL   FRESH PICKED FIG
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75862-019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Cetyl Alcohol (UNII: 936JST6JCN)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)
Dimethicone (UNII: 92RU3N3Y1O)
Stearic Acid (UNII: 4ELV7Z65AP)
Althaea Officinalis Root (UNII: TRW2FUF47H)
Cow Milk Fat (UNII: 463JZS0XJ3)
Mangifera Indica Seed Butter (UNII: 4OXD9M35X2)
Shea Butter (UNII: K49155WL9Y)
Ethylhexyl Palmitate (UNII: 2865993309)
Petrolatum (UNII: 4T6H12BN9U)
High Density Polyethylene (UNII: UG00KM4WR7)
Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)
Phenoxyethanol (UNII: HIE492ZZ3T)
Caprylyl Glycol (UNII: 00YIU5438U)
Sorbic Acid (UNII: X045WJ989B)
Carbomer Homopolymer Type C (UNII: 4Q93RCW27E)
Sodium Hydroxide (UNII: 55X04QC32I)
Edetate Sodium (UNII: MP1J8420LU)
Ultramarine Blue (UNII: I39WR998BI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75862-019-01	255 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	11/30/2011

GOURMET KITCHEN REGENERATING ANTI-BACTERIAL   SWEET PLUM
benzalkonium chloride lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75862-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Cetyl Alcohol (UNII: 936JST6JCN)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)
Dimethicone (UNII: 92RU3N3Y1O)
Stearic Acid (UNII: 4ELV7Z65AP)
Althaea Officinalis Root (UNII: TRW2FUF47H)
Cow Milk Fat (UNII: 463JZS0XJ3)
Mangifera Indica Seed Butter (UNII: 4OXD9M35X2)
Shea Butter (UNII: K49155WL9Y)
Ethylhexyl Palmitate (UNII: 2865993309)
Petrolatum (UNII: 4T6H12BN9U)
High Density Polyethylene (UNII: UG00KM4WR7)
Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)
Phenoxyethanol (UNII: HIE492ZZ3T)
Caprylyl Glycol (UNII: 00YIU5438U)
Sorbic Acid (UNII: X045WJ989B)
Carbomer Homopolymer Type C (UNII: 4Q93RCW27E)
Sodium Hydroxide (UNII: 55X04QC32I)
Edetate Sodium (UNII: MP1J8420LU)
Ultramarine Blue (UNII: I39WR998BI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75862-023-01	255 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	11/30/2011

Labeler - GANZ U.S.A., LLC (798785242)