FDA.reportPublic FDA data

Repair and Protect

Manufacturer
Blistex Inc.
Effective date
2025-01-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:53:36

Label at a glance#

ProductRepair and Protect
Active ingredientPETROLATUM
Label structure9 sections

Indications and uses

temporarily protects and helps relieve chapped or cracked lips helps prevent and protect from the drying effects of wind and cold weather

Dosage and administration

apply as needed

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 45.0% (w/w)

Purpose

OTC - PURPOSE SECTION

Lip protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects and helps relieve chapped or cracked lips
  • helps prevent and protect 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

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

  • apply as needed

Other information

STORAGE AND HANDLING SECTION

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

beeswax, butylene glycol, butyrospermum parkii (shea) butter, chamomilla recutita (matricaria) flower extract, ethylhexyl palmitate, helianthus annuus (sunflower) seed oil, lanolin, microcrystalline wax, octyldodecanol, ozokerite, paraffin, persea gratissima (avocado) oil, phenoxyethanol, phenyl trimethicone, silica dimethyl silylate, simmondsia chinensis (jojoba) seed oil, sodium hyaluronate, tocopheryl acetate

PRINCIPAL DISPLAY PANEL - 3.69 g Cylinder Blister Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Blistex®
NEW
Lip Protectant

DERMATOLOGIST RECOMMENDED*

REPAIR &
PROTECT

Relieves and Protects
Severely Dry, Chapped Lips

Smooth Formula for
Long-Lasting Moisture

Net Wt. 0.13 oz. (3.69 g)

PRINCIPAL DISPLAY PANEL - 3.69 g Cylinder Blister Pack
PRINCIPAL DISPLAY PANEL - 3.69 g Cylinder Blister Pack

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-1189-1Repair and Protect3.69 g in 1 CYLINDERSTICK3.693
10157-1189-1Repair and Protect1 in 1 BLISTER PACKSTICK13
10157-1189-2Repair and Protect2 in 1 BLISTER PACKSTICK23
10157-1189-2Repair and Protect3.69 g in 1 CYLINDERSTICK3.693

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-1189REPAIR AND PROTECT (PETROLATUM) STICK [BLISTEX INC.]3Current NDC, 4 package rows20250125_a51e1b67-e2c7-4b67-95db-07f5f3bdc068.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
10157-118910157-1189-1, 10157-1189-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
CERESINQ1LS2UJO3AIACT
LANOLIN7EV65EAW6HIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
OCTYLDODECANOL461N1O614YIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
YELLOW WAX2ZA36H0S2VIACT
SUNFLOWER OIL3W1JG795YIIACT
CHAMOMILEFGL3685T2XIACT
ETHYLHEXYL PALMITATE2865993309IACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
HYALURONATE SODIUMYSE9PPT4THIACT
AVOCADO OIL6VNO72PFC1IACT
JOJOBA OIL724GKU717MIACT
SHEA BUTTERK49155WL9YIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PARAFFINI9O0E3H2ZEIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
Repair and ProtectPETROLATUMBlistex Inc.a51e1b67-e2c7-4b67-95db-07f5f3bdc0682025-01-23WarningsExact identifier
ndc (package): 10157-1189-2
ndc (package): 10157-1189-1
ndc (product): 10157-1189
ndc11 (package): 10157118902
ndc11 (package): 10157118901
spl id: 8bdb42e7-c505-4521-a3a2-1fb67ec9b4c1
spl set id: a51e1b67-e2c7-4b67-95db-07f5f3bdc068

Reported adverse events (FAERS/openFDA)#

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