BLISTEX LIP OINTMENT

Manufacturer
HART Health
Effective date
2024-01-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:08:43

Label at a glance#

ProductBlistex Lip
Active ingredientDIMETHICONE, CAMPHOR OIL, MENTHOL, PHENOL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Dimethicone 1.1% (w/w)

Camphor 0.5% (w/w)

Menthol 0.6% (w/w)

Phenol 0.5% (w/w)

OTC - PURPOSE SECTION

Purpose:

Skin protectant

External analgesic

External analgesic

External analgesic

INDICATIONS & USAGE SECTION

Uses: for the temporary protection and relief of pain and itching associated with

  • minor lip irritation
  • chapped or cracked lips
  • cold sores

WARNINGS SECTION

Warnings: For external use only

OTC - DO NOT USE SECTION

Do not use

  • in the eyes or over large portions of the body
  • on deep or puncture wounds
  • on animal bites
  • on serious burns

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens
  • condition lasts for more than 7 days
  • symptoms 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. 1-800-222-1222

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 2 years of age and over: apply liberally to affected area not more than 3 to 4 times daily

Children under 2 years of age: ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Allontoin, Ammonium Hydroxide, Beeswax, Calcium Disodium EDTA, Calcium Hydroxide, Cetyl Alcohol, Flavors, Glycerin, Lanolin, Lauric Acid, Mineral Oil, Myristic Acid, Oleic Acid, Palmitic Acid, Paraffin, Petrolatum, Polyglyceryl-3 diisostearate, Potassium Hydroxide, Purified Water, SD Alcohol 36, Silica, Sodium Hydroxide, Sodium Saccharin, Stearyl Alcohol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Blistexv24f.jpgBlistexv24f.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1358989camphor 0.5 % / dimethicone 1.1 % / menthol 0.6 % / phenol 0.5 % Topical OintmentPSN4
1358989camphor 0.005 MG/MG / dimethicone 0.011 MG/MG / menthol 0.006 MG/MG / phenol 0.005 MG/MG Topical OintmentSCD4
1358989camphor 0.5 % / dimethicone 1.1 % / menthol 0.6 % / phenol 0.5 % Topical OintmentSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50332-0029-22024-02-15C16284748780-19855d018-d763-cd31-e053-dbdaa90ab51aBLISTEX LIP OINTMENT
50332-0029-22019-11-27C16284748780-19855d018-d763-cd31-e053-dbdaa90ab51aBLISTEX LIP OINTMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50332-0028-2Blistex Lip.5 g in 1 PACKETOINTMENT.54
50332-0028-2Blistex Lip25 in 1 BOX, UNIT-DOSEOINTMENT254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50332-0028BLISTEX LIP (DIMETHICONE, CAMPHOR, MENTHOL, PHENOL) OINTMENT [HART HEALTH]42 package rows20240217_63300820-80ca-432f-b86d-ef15d878671b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR OILACTIVE INGREDIENT75IZZ8Y7271
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O1
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
PHENOLACTIVE INGREDIENT339NCG44TV1
CAMPHOR OILACTIVE MOIETY75IZZ8Y7271
DIMETHICONEACTIVE MOIETY92RU3N3Y1O1
MENTHOLACTIVE MOIETYL7T10EIP3A1
PHENOLACTIVE MOIETY339NCG44TV1
ALLANTOININACTIVE INGREDIENT344S277G0Z1
CALCIUM HYDROXIDEINACTIVE INGREDIENTPF5DZW74VN1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
EDETATE CALCIUM DISODIUMINACTIVE INGREDIENT25IH6R4SGF1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
LANOLININACTIVE INGREDIENT7EV65EAW6H1
LAURIC ACIDINACTIVE INGREDIENT1160N9NU9U1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1
MYRISTIC ACIDINACTIVE INGREDIENT0I3V7S25AW1
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CP1
PALMITIC ACIDINACTIVE INGREDIENT2V16EO95H11
PARAFFININACTIVE INGREDIENTI9O0E3H2ZE1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1
POLYGLYCERYL-3 DIISOSTEARATEINACTIVE INGREDIENT46P231IQV81
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4T1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1Y1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50332-002850332-0028-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML · Source PDF

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 7 · 408 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IOINTMENT, AUGMENTED / TOPICAL0.11 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YSUPPOSITORY / VAGINAL8.5 mgExact identifier — unii candidate
12 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCAPSULE / ORAL172 mgExact identifier — unii candidate
13 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCAPSULE, DELAYED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS136.55 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / AURICULAR (OTIC)0.8 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii candidate
20 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPASTE / DENTAL0.6 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPOIL / TOPICAL43.29 %v/vExact identifier — unii candidate
30 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVENOUS456 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR27 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION, EXTENDED RELEASE / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YCREAM / TOPICAL162000 mgExact identifier — unii candidate
12 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, FILM COATED / ORAL8 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE / ORAL60 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAVITREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS78.36 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISPONGE / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRASPINALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCREAM / VAGINAL3 mgExact identifier — unii candidate
13 equally ranked IID candidates
OLEIC ACIDOLEIC ACID2UMI9U37CPCAPSULE / ORAL8759 mgExact identifier — unii candidate
11 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IAEROSOL, METERED / RESPIRATORY (INHALATION)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HLOTION / TOPICAL1.5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IJELLY / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / OPHTHALMIC0.1 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / RECTAL105 mgExact identifier — unii candidate
9 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YAEROSOL, FOAM / TOPICAL37 mgExact identifier — unii candidate
12 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL, METERED / TRANSDERMAL350 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / OPHTHALMIC6 mgExact identifier — unii candidate
174 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TINJECTION / INTRAVENOUSADJ PHExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TRANSDERMAL472 mgExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
POTASSIUM HYDROXIDEPOTASSIUM HYDROXIDEWZH3C48M4TCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
13 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii candidate
174 equally ranked IID candidates
EDETATE CALCIUM DISODIUMEDETATE CALCIUM DISODIUM25IH6R4SGFPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE CALCIUM DISODIUMEDETATE CALCIUM DISODIUM25IH6R4SGFCAPSULE / ORALNAExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE CALCIUM DISODIUMEDETATE CALCIUM DISODIUM25IH6R4SGFINJECTION, SOLUTION / SUBCUTANEOUS0.06 %w/vExact identifier — unii candidate
26 equally ranked IID candidates
STEARYL ALCOHOLSTEARYL ALCOHOL2KR89I4H1YLOTION / TOPICAL1140 mgExact identifier — unii candidate
12 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
CALCIUM HYDROXIDECALCIUM HYDROXIDEPF5DZW74VNINJECTION / INTRAVENOUS3.7 mgExact identifier — unii candidate
4 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / SUBMUCOSALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ITABLET, COATED / ORALNAExact identifier — unii candidate
174 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7dd5b472-551f-4bb3-abcb-b53e5fa2349763300820-80ca-432f-b86d-ef15d878671b2024-01-18WarningsExact identifier
spl id: 7dd5b472-551f-4bb3-abcb-b53e5fa23497
spl set id: 63300820-80ca-432f-b86d-ef15d878671b

Reported adverse events (FAERS/openFDA)#

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