FDA.reportPublic FDA data

Blistex Lip Medex

Manufacturer
Blistex Inc.
Effective date
2024-01-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:07:58

Label at a glance#

ProductBlistex Lip Medex
Active ingredientPETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), PHENOL
Label structure7 sections

Indications and uses

for the temporary relief of pain and itching associated with minor lip irritation temporarily protects and helps relieve chapped or cracked lips helps protect lips from the drying effects of wind and cold weather

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 ingredientsPurpose
Camphor 1.0% (w/w)External analgesic
Menthol 1.0% (w/w)External analgesic
Petrolatum 59.14% (w/w)Lip protectant
Phenol 0.54% (w/w)External analgesic

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of pain and itching associated with minor lip irritation
  • temporarily protects and helps relieve chapped or cracked lips
  • helps protect lips from the drying effects of wind and cold weather

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

beeswax, benzyl alcohol, diisopropyl adipate, flavors, fragrances, lanolin, menthoxypropanediol, microcrystalline wax, myristyl myristate, ricinus communis (castor) seed oil, saccharin, theobroma cacao (cocoa) seed butter

PRINCIPAL DISPLAY PANEL - 7.08 g Jar Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10157-8407-1

Blistex®

LIP PROTECTANT/
EXTERNAL ANALGESIC

LIP MEDEX®

Relieves Sore Lips &
Restores Moisture Balance

Quickly Cools & Comforts

NET WT. .25 oz (7.08g)

PRINCIPAL DISPLAY PANEL - 7.08 g Jar Blister Pack
PRINCIPAL DISPLAY PANEL - 7.08 g Jar Blister Pack

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-8407-1Blistex Lip Medex7.08 g in 1 JARPASTE7.083
10157-8407-1Blistex Lip Medex1 in 1 BLISTER PACKPASTE13
10157-8407-2Blistex Lip Medex1 in 1 BLISTER PACKPASTE13
10157-8407-2Blistex Lip Medex10.75 g in 1 JARPASTE10.753
10157-8407-3Blistex Lip Medex3 in 1 BLISTER PACKPASTE33
10157-8407-3Blistex Lip Medex7.08 g in 1 JARPASTE7.083
10157-8407-4Blistex Lip Medex7.08 g in 1 JARPASTE7.083
10157-8407-5Blistex Lip Medex10.75 g in 1 JARPASTE10.753

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-8407BLISTEX LIP MEDEX (PETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND PHENOL) PASTE [BLISTEX INC.]3Current NDC, Legacy NDC, 8 package rows20240127_8ad39005-9419-4f1a-a1ae-2f76d212455e.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10157-840710157-8407-1, 10157-8407-2, 10157-8407-3, 10157-8407-4, 10157-8407-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
PHENOL339NCG44TVACTIB
LANOLIN7EV65EAW6HIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
COCOA BUTTER512OYT1CRRIACT
YELLOW WAX2ZA36H0S2VIACT
CASTOR OILD5340Y2I9GIACT
MYRISTYL MYRISTATE4042ZC00DYIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
BENZYL ALCOHOLLKG8494WBHIACT
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOLKD6TZ2QICHIACT
MENTHYL SALICYLATE, (+/-)-43XOA705ZDIACT
SACCHARINFST467XS7DIACT
EUCALYPTUS OIL2R04ONI662IACT
CLOVE OIL578389D6D0IACT

Source Document#

Source XML

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
Blistex Lip MedexPETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND PHENOLBlistex Inc.8ad39005-9419-4f1a-a1ae-2f76d212455e2024-01-26WarningsExact identifier
ndc (package): 10157-8407-2
ndc (package): 10157-8407-1
ndc (package): 10157-8407-4
ndc (package): 10157-8407-5
ndc (package): 10157-8407-3
ndc (product): 10157-8407
ndc11 (package): 10157840704
ndc11 (package): 10157840702
ndc11 (package): 10157840701
ndc11 (package): 10157840705
ndc11 (package): 10157840703
spl id: c9b9b923-9098-499f-bfa3-509400bb9f82
spl set id: 8ad39005-9419-4f1a-a1ae-2f76d212455e

Reported adverse events (FAERS/openFDA)#

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