LIP REMEDY MEDICINAL LIP BALM  BLUE- petrolatum stick 
LIP REMEDY MEDICINAL LIP BALM  GREEN- petrolatum stick 
LIP REMEDY MEDICINAL LIP BALM  RED- petrolatum stick 
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.

----------

time & again®
LIP REMEDY medicinal lip balm
with Menthol and Cocoa Seed Butter

Drug Facts

Active ingredients

Petrolatum 32.3%

Purposes

Skin Protectant

Uses

Warnings

When using this product keep out of eyes.

Stop use and ask a doctor if

  • irritation or rash occurs
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

  • store at 20-25°C (68-77°F)

  • this is a personal care item and should be used by one individual
  • 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

isopropyl lanolate, lanolin, ozokerite wax, euphorbia cerifera (candelilla) wax, isopropyl myristate, polybutene, diisopropyl adipate, myristyl myristate, flavor, theobroma cacao (cocoa) seed butter, camphor, menthol, phenol, yellow 10 lake, red 6 lake, saccharin, menthoxypropanediol

PRINCIPAL DISPLAY PANEL - 4 g Blue Carton

Net wt. 4 g (0.14 Oz.)

time & again®
LIP REMEDY medicinal lip balm
with Menthol and Cocoa Seed Butter

Soothes, relieves
and helps to protect
dry chapped lips.

Principal Display Panel - 4 g Blue Carton

PRINCIPAL DISPLAY PANEL - 4 g Green Carton

Net wt. 4 g (0.14 Oz.)

time & again®
LIP REMEDY medicinal lip balm
with Menthol and Cocoa Seed Butter

Soothes, relieves
and helps to protect
dry chapped lips.

Principal Display Panel - 4 g Green Carton

PRINCIPAL DISPLAY PANEL - 4 g Red Carton

Net wt. 4 g (0.14 Oz.)

time & again®
LIP REMEDY medicinal lip balm
with Menthol and Cocoa Seed Butter

Soothes, relieves
and helps to protect
dry chapped lips.

Principal Display Panel - 4 g Red Carton
LIP REMEDY MEDICINAL LIP BALM   BLUE
petrolatum stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75862-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM32.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
CERESIN (UNII: Q1LS2UJO3A)  
CANDELILLA WAX (UNII: WL0328HX19)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
COCOA BUTTER (UNII: 512OYT1CRR)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
MENTHOL (UNII: L7T10EIP3A)  
PHENOL (UNII: 339NCG44TV)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
D&C RED NO. 6 (UNII: 481744AI4O)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SACCHARIN (UNII: FST467XS7D)  
Product Characteristics
ColorYELLOW (BRIGHT YELLOW TO REDDISH GOLD) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75862-012-501 in 1 BOX
14 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34602/01/2011
LIP REMEDY MEDICINAL LIP BALM   GREEN
petrolatum stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75862-013
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM32.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
CERESIN (UNII: Q1LS2UJO3A)  
CANDELILLA WAX (UNII: WL0328HX19)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
COCOA BUTTER (UNII: 512OYT1CRR)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
MENTHOL (UNII: L7T10EIP3A)  
PHENOL (UNII: 339NCG44TV)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
D&C RED NO. 6 (UNII: 481744AI4O)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SACCHARIN (UNII: FST467XS7D)  
Product Characteristics
ColorYELLOW (BRIGHT YELLOW TO REDDISH GOLD) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75862-013-501 in 1 BOX
14 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34602/01/2011
LIP REMEDY MEDICINAL LIP BALM   RED
petrolatum stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75862-014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM32.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
CERESIN (UNII: Q1LS2UJO3A)  
CANDELILLA WAX (UNII: WL0328HX19)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
COCOA BUTTER (UNII: 512OYT1CRR)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
MENTHOL (UNII: L7T10EIP3A)  
PHENOL (UNII: 339NCG44TV)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
D&C RED NO. 6 (UNII: 481744AI4O)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
SACCHARIN (UNII: FST467XS7D)  
Product Characteristics
ColorYELLOW (BRIGHT YELLOW TO REDDISH GOLD) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75862-014-501 in 1 BOX
14 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34602/01/2011
Labeler - GANZ U.S.A., LLC (798785242)

Revised: 2/2011
Document Id: c0595792-471f-43c5-985b-8074f12a9c9f
Set id: 0fe75852-2cb2-4d06-a2fe-56abbc8fe21e
Version: 1
Effective Time: 20110216
 
GANZ U.S.A., LLC