GOURMET KITCHEN REGENERATING ANTI-BACTERIAL  FRESH PICKED FIG- benzalkonium chloride lotion 
GOURMET KITCHEN REGENERATING ANTI-BACTERIAL  SWEET PLUM- benzalkonium chloride lotion 
GANZ U.S.A., LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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time & again®
REGENERATING
ANTI-BACTERIAL
hand cream

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

Other information

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

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)

PRINCIPAL DISPLAY PANEL - 255 mL Bottle Label
GOURMET KITCHEN REGENERATING ANTI-BACTERIAL   FRESH PICKED FIG
benzalkonium chloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75862-019
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75862-019-01255 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E11/30/2011
GOURMET KITCHEN REGENERATING ANTI-BACTERIAL   SWEET PLUM
benzalkonium chloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75862-023
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75862-023-01255 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E11/30/2011
Labeler - GANZ U.S.A., LLC (798785242)

Revised: 12/2011
Document Id: fb6e2d48-8b3b-4062-b097-9fbea6ce07d5
Set id: 124f2681-f52b-43cd-84bb-bd8c245344f5
Version: 1
Effective Time: 20111207
 
GANZ U.S.A., LLC