LIP REMEDY MEDICINAL LIP BALM- petrolatum stick LIP REMEDY MEDICINAL LIP BALM- petrolatum stick LIP REMEDY MEDICINAL LIP BALM- petrolatum stick

Lip Remedy Medicinal Lip Balm by

Drug Labeling and Warnings

Lip Remedy Medicinal Lip Balm 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 ingredients

Petrolatum 32.3%

Purposes

Skin Protectant

Uses

• temporarily protects and helps relieve chapped, cracked lips
• temporarily protects lips from drying effects of wind and cold weather

Warnings

• For external use only

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

• Apply as needed.

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 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 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.

INGREDIENTS AND APPEARANCE

LIP REMEDY MEDICINAL LIP BALM   BLUE
petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75862-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	32.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	YELLOW (BRIGHT YELLOW TO REDDISH GOLD)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75862-012-50	1 in 1 BOX
1		4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part346	02/01/2011

LIP REMEDY MEDICINAL LIP BALM   GREEN
petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75862-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	32.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	YELLOW (BRIGHT YELLOW TO REDDISH GOLD)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75862-013-50	1 in 1 BOX
1		4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part346	02/01/2011

LIP REMEDY MEDICINAL LIP BALM   RED
petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75862-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	32.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	YELLOW (BRIGHT YELLOW TO REDDISH GOLD)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75862-014-50	1 in 1 BOX
1		4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part346	02/01/2011

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