Blistex ® Medicated Lip ointment

Manufacturer: Blistex Inc.
Effective date: 2024-12-11
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:42:38

Label at a glance#

ProductBlistex Medicated

Active ingredientDimethicone, Camphor (synthetic), Menthol, unspecified form, Phenol

Label structure7 sections

Indications and uses

for the temporary relief of pain and itching associated with minor lip irritation or cold sores temporarily protects and helps relieve chapped or cracked lips

Dosage and administration

adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily children under 2 years of age: Consult a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients	Purpose
Camphor 0.5% (w/w)	External analgesic
Dimethicone 1.1% (w/w)	Lip protectant
Menthol 0.625% (w/w)	External analgesic
Phenol 0.5% (w/w)	External analgesic

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of pain and itching associated with minor lip irritation or cold sores
temporarily protects and helps relieve chapped or cracked lips

Warnings

WARNINGS SECTION

For external use only

Do not use on

OTC - DO NOT USE SECTION

deep or puncture wounds
animal bites
serious burns

When using this product

OTC - WHEN USING SECTION

do not get into eyes
do not apply over large areas of the body or bandage

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens
symptoms last 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

adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily
children under 2 years of age: Consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

allantoin, ammonium hydroxide, beeswax, calcium disodium EDTA, calcium hydroxide, cetyl alcohol, flavors, glycerin, hydrated silica, lanolin, lauric acid, mineral oil, myristic acid, oleic acid, palmitic acid, paraffin, petrolatum, polyglyceryl-3 diisostearate, potassium hydroxide, purified water, SD alcohol 36, sodium hydroxide, sodium saccharin, stearyl alcohol

PRINCIPAL DISPLAY PANEL - 6 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Penetrating
Medication
And Moisture

Blistex_®
MEDICATED LIP OINTMENT

PRINCIPAL DISPLAY PANEL - 6 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2107300	camphor 0.5 % / dimethicone 1.1 % / menthol 0.625 % / phenol 0.5 % Topical Ointment	PSN	4
2107300	camphor 0.005 MG/MG / dimethicone 0.011 MG/MG / menthol 0.00625 MG/MG / phenol 0.005 MG/MG Topical Ointment	SCD	4
2107300	camphor 0.5 % / dimethicone 1.1 % / menthol 0.625 % / phenol 0.5 % Topical Ointment	SY	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIMETHICONE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10157-9951-1	Blistex Medicated	6 g in 1 TUBE	OINTMENT	6	4
10157-9951-2	Blistex Medicated	1 in 1 CARTON	OINTMENT	1	4
10157-9951-3	Blistex Medicated	10 g in 1 TUBE	OINTMENT	10	4
10157-9951-4	Blistex Medicated	2.25 g in 1 TUBE	OINTMENT	2.25	4
10157-9951-5	Blistex Medicated	8 g in 1 TUBE	OINTMENT	8	4
10157-9951-6	Blistex Medicated	6 g in 1 TUBE	OINTMENT	6	4
10157-9951-7	Blistex Medicated	3 in 1 CARTON	OINTMENT	3	4
10157-9951-7	Blistex Medicated	6 g in 1 TUBE	OINTMENT	6	4
10157-9951-8	Blistex Medicated	4 in 1 CARTON	OINTMENT	4	4
10157-9951-8	Blistex Medicated	6 g in 1 TUBE	OINTMENT	6	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10157-9951	BLISTEX MEDICATED (DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL) OINTMENT [BLISTEX INC.]	4	Current NDC, Legacy NDC, 10 package rows	20241213_e95439d3-f12b-4c1c-999a-79f2ddba4cfb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10157-9951-2	GM - Gram	10157-9951	95deb1e4-cebc-4c0f-abdf-bea69a3668c1	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Camphor (synthetic)	ACTIVE INGREDIENT	5TJD82A1ET	1
Dimethicone	ACTIVE INGREDIENT	92RU3N3Y1O	1
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	1
Phenol	ACTIVE INGREDIENT	339NCG44TV	1
Camphor (synthetic)	ACTIVE MOIETY	5TJD82A1ET	1
Dimethicone	ACTIVE MOIETY	92RU3N3Y1O	1
Menthol	ACTIVE MOIETY	L7T10EIP3A	1
Phenol	ACTIVE MOIETY	339NCG44TV	1
allantoin	INACTIVE INGREDIENT	344S277G0Z	1
ammonia	INACTIVE INGREDIENT	5138Q19F1X	1
calcium hydroxide	INACTIVE INGREDIENT	PF5DZW74VN	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	1
edetate calcium disodium anhydrous	INACTIVE INGREDIENT	8U5D034955	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
hydrated silica	INACTIVE INGREDIENT	Y6O7T4G8P9	1
lanolin	INACTIVE INGREDIENT	7EV65EAW6H	1
lauric acid	INACTIVE INGREDIENT	1160N9NU9U	1
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	1
myristic acid	INACTIVE INGREDIENT	0I3V7S25AW	1
oleic acid	INACTIVE INGREDIENT	2UMI9U37CP	1
palmitic acid	INACTIVE INGREDIENT	2V16EO95H1	1
paraffin	INACTIVE INGREDIENT	I9O0E3H2ZE	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	1
polyglyceryl-3 diisostearate	INACTIVE INGREDIENT	46P231IQV8	1
potassium hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	1
saccharin sodium	INACTIVE INGREDIENT	SB8ZUX40TY	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	1
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	1
water	INACTIVE INGREDIENT	059QF0KO0R	1
yellow wax	INACTIVE INGREDIENT	2ZA36H0S2V	1

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

Blistex Medicated
Dimethicone, Camphor (synthetic), Menthol, and Phenol
Dimethicone
Camphor (synthetic)
Menthol, unspecified form
Phenol
allantoin
ammonia
yellow wax
edetate calcium disodium anhydrous
calcium hydroxide
cetyl alcohol
glycerin
hydrated silica
lanolin
lauric acid
mineral oil
myristic acid
oleic acid
palmitic acid
paraffin
petrolatum
polyglyceryl-3 diisostearate
potassium hydroxide
water
sodium hydroxide
saccharin sodium
stearyl alcohol

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10157-9951	10157-9951-1, 10157-9951-3, 10157-9951-4, 10157-9951-5, 10157-9951-6, 10157-9951-2, 10157-9951-7, 10157-9951-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Dimethicone	92RU3N3Y1O	ACTIB
Camphor (synthetic)	5TJD82A1ET	ACTIB
Menthol, unspecified form	L7T10EIP3A	ACTIB
Phenol	339NCG44TV	ACTIB
allantoin	344S277G0Z	IACT
ammonia	5138Q19F1X	IACT
yellow wax	2ZA36H0S2V	IACT
edetate calcium disodium anhydrous	8U5D034955	IACT
calcium hydroxide	PF5DZW74VN	IACT
cetyl alcohol	936JST6JCN	IACT
glycerin	PDC6A3C0OX	IACT
hydrated silica	Y6O7T4G8P9	IACT
lanolin	7EV65EAW6H	IACT
lauric acid	1160N9NU9U	IACT
mineral oil	T5L8T28FGP	IACT
myristic acid	0I3V7S25AW	IACT
oleic acid	2UMI9U37CP	IACT
palmitic acid	2V16EO95H1	IACT
paraffin	I9O0E3H2ZE	IACT
petrolatum	4T6H12BN9U	IACT
polyglyceryl-3 diisostearate	46P231IQV8	IACT
potassium hydroxide	WZH3C48M4T	IACT
water	059QF0KO0R	IACT
sodium hydroxide	55X04QC32I	IACT
saccharin sodium	SB8ZUX40TY	IACT
stearyl alcohol	2KR89I4H1Y	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 5 · 288 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
calcium hydroxide	CALCIUM HYDROXIDE	PF5DZW74VN	INJECTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 36 equally ranked IID candidates
potassium hydroxide	POTASSIUM HYDROXIDE	WZH3C48M4T	CREAM / TOPICAL	0.5 %w/w		Exact identifier — unii+route 36 equally ranked IID candidates
palmitic acid	PALMITIC ACID	2V16EO95H1	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
calcium hydroxide	CALCIUM HYDROXIDE	PF5DZW74VN	CAPSULE, EXTENDED RELEASE / ORAL		14 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
paraffin	PARAFFIN	I9O0E3H2ZE	OINTMENT / TOPICAL		2860 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
potassium hydroxide	POTASSIUM HYDROXIDE	WZH3C48M4T	CREAM / TOPICAL	0.5 %w/w		Exact identifier — unii+route 36 equally ranked IID candidates
paraffin	PARAFFIN	I9O0E3H2ZE	OINTMENT / TOPICAL		2860 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
ammonia	AMMONIA SOLUTION	5138Q19F1X	LOTION / TOPICAL	ADJ PH		Exact identifier — unii+route 27 equally ranked IID candidates
palmitic acid	PALMITIC ACID	2V16EO95H1	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
ammonia	AMMONIA SOLUTION	5138Q19F1X	LOTION / TOPICAL	ADJ PH		Exact identifier — unii+route 27 equally ranked IID candidates
oleic acid	OLEIC ACID	2UMI9U37CP	GEL, METERED / TOPICAL		88 mg	Exact identifier — unii+route 27 equally ranked IID candidates
lanolin	LANOLIN	7EV65EAW6H	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
calcium hydroxide	CALCIUM HYDROXIDE	PF5DZW74VN	CAPSULE, EXTENDED RELEASE / ORAL		14 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
myristic acid	MYRISTIC ACID	0I3V7S25AW	CAPSULE, EXTENDED RELEASE / ORAL		1721 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
myristic acid	MYRISTIC ACID	0I3V7S25AW	AEROSOL, FOAM / VAGINAL	2 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
potassium hydroxide	POTASSIUM HYDROXIDE	WZH3C48M4T	AEROSOL, FOAM / TOPICAL	ADJ PH		Exact identifier — unii+route 36 equally ranked IID candidates
oleic acid	OLEIC ACID	2UMI9U37CP	SOLUTION / TOPICAL	7.4 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
calcium hydroxide	CALCIUM HYDROXIDE	PF5DZW74VN	CAPSULE, EXTENDED RELEASE / ORAL		14 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
potassium hydroxide	POTASSIUM HYDROXIDE	WZH3C48M4T	SOLUTION / TOPICAL	14.02 %w/w		Exact identifier — unii+route 36 equally ranked IID candidates
ammonia	AMMONIA SOLUTION	5138Q19F1X	CREAM / TOPICAL	5.72 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
oleic acid	OLEIC ACID	2UMI9U37CP	CREAM / TOPICAL	25 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
oleic acid	OLEIC ACID	2UMI9U37CP	GEL, METERED / TOPICAL		88 mg	Exact identifier — unii+route 27 equally ranked IID candidates
paraffin	PARAFFIN	I9O0E3H2ZE	OINTMENT / TOPICAL		2860 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
allantoin	ALLANTOIN	344S277G0Z	GEL / TOPICAL		8 mg	Exact identifier — unii+route 9 equally ranked IID candidates
potassium hydroxide	POTASSIUM HYDROXIDE	WZH3C48M4T	SOLUTION / TOPICAL	14.02 %w/w		Exact identifier — unii+route 36 equally ranked IID candidates
oleic acid	OLEIC ACID	2UMI9U37CP	SOLUTION / TOPICAL	7.4 %w/w		Exact identifier — unii+route 27 equally ranked IID candidates
allantoin	ALLANTOIN	344S277G0Z	GEL / TOPICAL		8 mg	Exact identifier — unii+route 9 equally ranked IID candidates
edetate calcium disodium anhydrous	EDETATE CALCIUM DISODIUM ANHYDROUS	8U5D034955	INJECTION, SOLUTION / INTRAVASCULAR	0.05 %w/v		Exact identifier — unii candidate 27 equally ranked IID candidates
edetate calcium disodium anhydrous	EDETATE CALCIUM DISODIUM ANHYDROUS	8U5D034955	INJECTION / INTRA-ARTERIAL		23 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
potassium hydroxide	POTASSIUM HYDROXIDE	WZH3C48M4T	CREAM / TOPICAL	0.5 %w/w		Exact identifier — unii+route 36 equally ranked IID candidates
potassium hydroxide	POTASSIUM HYDROXIDE	WZH3C48M4T	GEL / TOPICAL		3 mg	Exact identifier — unii+route 36 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	OINTMENT / TOPICAL		9938 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
calcium hydroxide	CALCIUM HYDROXIDE	PF5DZW74VN	SUSPENSION / ORAL	ADJ PH		Exact identifier — unii candidate 36 equally ranked IID candidates
potassium hydroxide	POTASSIUM HYDROXIDE	WZH3C48M4T	SOLUTION / TOPICAL	14.02 %w/w		Exact identifier — unii+route 36 equally ranked IID candidates
ammonia	AMMONIA SOLUTION	5138Q19F1X	LOTION / TOPICAL	ADJ PH		Exact identifier — unii+route 27 equally ranked IID candidates
potassium hydroxide	POTASSIUM HYDROXIDE	WZH3C48M4T	SOLUTION / TOPICAL	14.02 %w/w		Exact identifier — unii+route 36 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
edetate calcium disodium anhydrous	EDETATE CALCIUM DISODIUM ANHYDROUS	8U5D034955	INJECTION / INTRA-ARTERIAL		23 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
potassium hydroxide	POTASSIUM HYDROXIDE	WZH3C48M4T	SOLUTION / TOPICAL	14.02 %w/w		Exact identifier — unii+route 36 equally ranked IID candidates
potassium hydroxide	POTASSIUM HYDROXIDE	WZH3C48M4T	CREAM / TOPICAL	0.5 %w/w		Exact identifier — unii+route 36 equally ranked IID candidates
lanolin	LANOLIN	7EV65EAW6H	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
lanolin	LANOLIN	7EV65EAW6H	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
lanolin	LANOLIN	7EV65EAW6H	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
edetate calcium disodium anhydrous	EDETATE CALCIUM DISODIUM ANHYDROUS	8U5D034955	INJECTION / INTRA-ARTERIAL		23 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
potassium hydroxide	POTASSIUM HYDROXIDE	WZH3C48M4T	GEL / TOPICAL		3 mg	Exact identifier — unii+route 36 equally ranked IID candidates
edetate calcium disodium anhydrous	EDETATE CALCIUM DISODIUM ANHYDROUS	8U5D034955	INJECTION / INTRAVENOUS		23 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
calcium hydroxide	CALCIUM HYDROXIDE	PF5DZW74VN	INJECTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 36 equally ranked IID candidates
oleic acid	OLEIC ACID	2UMI9U37CP	GEL, METERED / TOPICAL		88 mg	Exact identifier — unii+route 27 equally ranked IID candidates
edetate calcium disodium anhydrous	EDETATE CALCIUM DISODIUM ANHYDROUS	8U5D034955	INJECTION / INTRAVENOUS		23 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
cetyl alcohol	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	OINTMENT / TOPICAL		9938 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
paraffin	PARAFFIN	I9O0E3H2ZE	OINTMENT / TOPICAL		2860 mg	Exact identifier — unii+route+dosage form 9 equally ranked IID candidates
potassium hydroxide	POTASSIUM HYDROXIDE	WZH3C48M4T	GEL / TOPICAL		3 mg	Exact identifier — unii+route 36 equally ranked IID candidates
edetate calcium disodium anhydrous	EDETATE CALCIUM DISODIUM ANHYDROUS	8U5D034955	INJECTION / INTRAVENOUS		23 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
calcium hydroxide	CALCIUM HYDROXIDE	PF5DZW74VN	INJECTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 36 equally ranked IID candidates
allantoin	ALLANTOIN	344S277G0Z	GEL / TOPICAL		8 mg	Exact identifier — unii+route 9 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
Blistex Medicated	DIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOL	Blistex Inc.	e95439d3-f12b-4c1c-999a-79f2ddba4cfb	2024-12-11	Warnings	Exact identifier ndc (package): 10157-9951-1 ndc (package): 10157-9951-8 ndc (package): 10157-9951-6 ndc (package): 10157-9951-3 ndc (package): 10157-9951-5 ndc (package): 10157-9951-7 ndc (package): 10157-9951-4 ndc (package): 10157-9951-2 ndc (product): 10157-9951 ndc11 (package): 10157995107 ndc11 (package): 10157995104 ndc11 (package): 10157995106 ndc11 (package): 10157995102 ndc11 (package): 10157995105 ndc11 (package): 10157995108 ndc11 (package): 10157995101 ndc11 (package): 10157995103 spl id: 36a0ff8e-6ede-4902-a8ec-a71496008247 spl set id: e95439d3-f12b-4c1c-999a-79f2ddba4cfb

Reported adverse events (FAERS/openFDA)#

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