Lip Remedy Medicinal Lip Balm

Manufacturer: GANZ U.S.A., LLC
Effective date: 2011-02-16
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:27:16

Label at a glance#

ProductLip Remedy Medicinal Lip Balm BLUE

Active ingredientPETROLATUM

Label structure11 sections

Indications and uses

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

Dosage and administration

Apply as needed.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 32.3%

Purposes

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product keep out of eyes.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Other information

SPL UNCLASSIFIED SECTION

STORAGE AND HANDLING SECTION

store at 20-25°C (68-77°F)

SPL UNCLASSIFIED SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1110506	petrolatum 32.3 % Medicated Lip Balm	PSN	1
1110506	petrolatum 0.323 MG/MG Topical Ointment	SCD	1
1110506	petrolatum 32.3 % Medicated Lip Balm	SY	1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
75862-012-50	2019-10-29	C162847	48780-1	960f7f55-c302-8e05-e053-dbdaa90a074a	time & again ® LIP REMEDY medicinal lip balm with Menthol and Cocoa Seed Butter
75862-013-50	2019-10-29	C162847	48780-1	960f7f55-c302-8e05-e053-dbdaa90a074a	time & again ® LIP REMEDY medicinal lip balm with Menthol and Cocoa Seed Butter
75862-014-50	2019-10-29	C162847	48780-1	960f7f55-c302-8e05-e053-dbdaa90a074a	time & again ® LIP REMEDY medicinal lip balm with Menthol and Cocoa Seed Butter

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
75862-012-50	Lip Remedy Medicinal Lip Balm BLUE	1 in 1 BOX	STICK	1	1
75862-012-50	Lip Remedy Medicinal Lip Balm BLUE	4 g in 1 TUBE	STICK	4	1
75862-013-50	Lip Remedy Medicinal Lip Balm GREEN	1 in 1 BOX	STICK	1	1
75862-013-50	Lip Remedy Medicinal Lip Balm GREEN	4 g in 1 TUBE	STICK	4	1
75862-014-50	Lip Remedy Medicinal Lip Balm RED	4 g in 1 TUBE	STICK	4	1
75862-014-50	Lip Remedy Medicinal Lip Balm RED	1 in 1 BOX	STICK	1	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75862-012	LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK [GANZ U.S.A., LLC]	1	Legacy NDC, 2 package rows	20110222_0fe75852-2cb2-4d06-a2fe-56abbc8fe21e.zip
75862-013	LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK [GANZ U.S.A., LLC]	1	Legacy NDC, 2 package rows	20110222_0fe75852-2cb2-4d06-a2fe-56abbc8fe21e.zip
75862-014	LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK LIP REMEDY MEDICINAL LIP BALM (PETROLATUM) STICK [GANZ U.S.A., LLC]	1	Legacy NDC, 2 package rows	20110222_0fe75852-2cb2-4d06-a2fe-56abbc8fe21e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	1
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	1
CAMPHOR (SYNTHETIC)	INACTIVE INGREDIENT	5TJD82A1ET	1
CANDELILLA WAX	INACTIVE INGREDIENT	WL0328HX19	1
CERESIN	INACTIVE INGREDIENT	Q1LS2UJO3A	1
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	1
D&C RED NO. 6	INACTIVE INGREDIENT	481744AI4O	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	1
DIISOPROPYL ADIPATE	INACTIVE INGREDIENT	P7E6YFV72X	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	1
MYRISTYL MYRISTATE	INACTIVE INGREDIENT	4042ZC00DY	1
PHENOL	INACTIVE INGREDIENT	339NCG44TV	1
SACCHARIN	INACTIVE INGREDIENT	FST467XS7D	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

Lip Remedy Medicinal Lip Balm BLUE
PETROLATUM
LANOLIN
CERESIN
CANDELILLA WAX
ISOPROPYL MYRISTATE
DIISOPROPYL ADIPATE
MYRISTYL MYRISTATE
COCOA BUTTER
CAMPHOR (SYNTHETIC)
MENTHOL
PHENOL
D&C YELLOW NO. 10
D&C RED NO. 6
ALUMINUM OXIDE
SACCHARIN
Lip Remedy Medicinal Lip Balm GREEN
Lip Remedy Medicinal Lip Balm RED

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
75862-012	75862-012-50
75862-013	75862-013-50
75862-014	75862-014-50

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PETROLATUM	4T6H12BN9U	ACTIB
LANOLIN	7EV65EAW6H	IACT
CERESIN	Q1LS2UJO3A	IACT
CANDELILLA WAX	WL0328HX19	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
DIISOPROPYL ADIPATE	P7E6YFV72X	IACT
MYRISTYL MYRISTATE	4042ZC00DY	IACT
COCOA BUTTER	512OYT1CRR	IACT
CAMPHOR (SYNTHETIC)	5TJD82A1ET	IACT
MENTHOL	L7T10EIP3A	IACT
PHENOL	339NCG44TV	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
D&C RED NO. 6	481744AI4O	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
SACCHARIN	FST467XS7D	IACT
PETROLATUM	4T6H12BN9U	ACTIB
LANOLIN	7EV65EAW6H	IACT
CERESIN	Q1LS2UJO3A	IACT
CANDELILLA WAX	WL0328HX19	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
DIISOPROPYL ADIPATE	P7E6YFV72X	IACT
MYRISTYL MYRISTATE	4042ZC00DY	IACT
COCOA BUTTER	512OYT1CRR	IACT
CAMPHOR (SYNTHETIC)	5TJD82A1ET	IACT
MENTHOL	L7T10EIP3A	IACT
PHENOL	339NCG44TV	IACT
D&C YELLOW NO. 10	35SW5USQ3G	IACT
D&C RED NO. 6	481744AI4O	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
SACCHARIN	FST467XS7D	IACT
PETROLATUM	4T6H12BN9U	ACTIB
LANOLIN	7EV65EAW6H	IACT
CERESIN	Q1LS2UJO3A	IACT
CANDELILLA WAX	WL0328HX19	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
DIISOPROPYL ADIPATE	P7E6YFV72X	IACT
MYRISTYL MYRISTATE	4042ZC00DY	IACT
COCOA BUTTER	512OYT1CRR	IACT
CAMPHOR (SYNTHETIC)	5TJD82A1ET	IACT
MENTHOL	L7T10EIP3A	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 135 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, LIQUID FILLED / ORAL	1.51 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SYRUP / ORAL		4 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / ORAL	0.58 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	OIL / AURICULAR (OTIC)		36 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, EXTENDED RELEASE / ORAL		14 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION / INTRAVENOUS		48 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	CREAM / VAGINAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CAPSULE, EXTENDED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	JELLY / NASAL	32.5 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	2 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN	SACCHARIN	FST467XS7D	DROPS / ORAL	20 mg/1ml		Exact identifier — unii candidate 16 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
ALUMINUM OXIDE	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SUSPENSION / ORAL	20 mg/5ml		Exact identifier — unii candidate 31 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SYRUP / ORAL	7.5 mg/5ml		Exact identifier — unii candidate 24 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	POWDER / ORAL		48 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET, ORALLY DISINTEGRATING / ORAL	14 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
DIISOPROPYL ADIPATE	DIISOPROPYL ADIPATE	P7E6YFV72X	GEL / TRANSDERMAL	1.5 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL, FOAM / TOPICAL		144 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	MOUTHWASH / BUCCAL	0.15 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	CREAM / TOPICAL		65000 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	FILM, EXTENDED RELEASE / TRANSDERMAL	20.4 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
SACCHARIN	SACCHARIN	FST467XS7D	OINTMENT / TOPICAL	0.5 %w/w		Exact identifier — unii candidate 16 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION, CONCENTRATE / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET, EXTENDED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, DELAYED RELEASE / ORAL	1.9 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SPRAY / TOPICAL		3665 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SYSTEM / TRANSDERMAL		113 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 19 equally ranked IID candidates
SACCHARIN	SACCHARIN	FST467XS7D	POWDER, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	SPRAY / NASAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	INHALANT / NASAL	32 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, FILM COATED / ORAL	120 mg		Exact identifier — unii candidate 31 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	LOTION / TOPICAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET / ORAL		4 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	CONCENTRATE / ORAL	0.03 mg/1ml		Exact identifier — unii candidate 31 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SOLUTION / ORAL		3 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SOAP / TOPICAL	1.4 %w/w		Exact identifier — unii candidate 31 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	TABLET / SUBLINGUAL		2 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	OIL / TOPICAL		213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	SHAMPOO / TOPICAL	NA		Exact identifier — unii candidate 31 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	POWDER, FOR SUSPENSION / ORAL		76 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / OPHTHALMIC	3 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SUSPENSION / AURICULAR (OTIC)	0.02 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
SACCHARIN	SACCHARIN	FST467XS7D	PASTE, DENTIFRICE / DENTAL	0.23 %w/w		Exact identifier — unii candidate 16 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	SUSPENSION / ORAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
CANDELILLA WAX	CANDELILLA WAX	WL0328HX19	TABLET, FILM COATED / ORAL	0.8 mg		Exact identifier — unii candidate 4 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION / INTRADERMAL	0.25 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	DROPS / NASAL	40.32 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	LOTION / TOPICAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SYSTEM / TOPICAL		7 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
SACCHARIN	SACCHARIN	FST467XS7D	TABLET / ORAL	1.6 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
SACCHARIN	SACCHARIN	FST467XS7D	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
MENTHOL	MENTHOL	L7T10EIP3A	CONCENTRATE / ORAL	0.05 mg/5ml		Exact identifier — unii candidate 24 equally ranked IID candidates
D&C YELLOW NO. 10	D&C YELLOW NO. 10	35SW5USQ3G	TABLET, CHEWABLE / ORAL		4 mg	Exact identifier — unii candidate 31 equally ranked IID candidates
DIISOPROPYL ADIPATE	DIISOPROPYL ADIPATE	P7E6YFV72X	SOLUTION / TOPICAL		815 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
PHENOL	PHENOL	339NCG44TV	INJECTION / INTRALESIONAL	0.5 %w/v		Exact identifier — unii candidate 19 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
c0595792-471f-43c5-985b-8074f12a9c9f			0fe75852-2cb2-4d06-a2fe-56abbc8fe21e	2011-02-16	Warnings	Exact identifier spl id: c0595792-471f-43c5-985b-8074f12a9c9f spl set id: 0fe75852-2cb2-4d06-a2fe-56abbc8fe21e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.