FDA.reportPublic FDA data

Tenderphor

Manufacturer
ASTONEA LABS PRIVATE LIMITED
Effective date
2024-06-25
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:14:18

Label at a glance#

ProductTenderphor
Active ingredientPETROLATUM
Label structure12 sections

Indications and uses

Temporarily protects minor cuts, scrapes, burns. Temporarily protects and helps relieve chapped or cracked skin and lips. Helps protect skin from the drying effects of wind and cold weather.

Dosage and administration

Apply liberally to affected area as needed.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 44.28%

Purpose:

OTC - PURPOSE SECTION

Skin Protectant

Uses:

DOSAGE & ADMINISTRATION SECTION

  • Temporarily protects minor cuts, scrapes, burns.
  • Temporarily protects and helps relieve chapped or cracked skin and lips.
  • Helps protect skin from the drying effects of wind and cold weather.

Warnings:

WARNINGS SECTION

​For external use only.

Warnings:

OTC - WHEN USING SECTION

Avoid contact with eyes. In case of contact, flush thoroughly with water.

Warnings:

OTC - ASK DOCTOR SECTION

Stop and ask a doctor if

  • condition worsens
  • ​symptoms last more than 7 days or clear up and occur again within a few days

​Warnings:

OTC - DO NOT USE SECTION

Do not use ​on deep or puncture wounds, animal bites, or serious wounds.

​Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

​Incase of accidental ingestion contact a Physician or Poison Control Center right away.

Directions:

INDICATIONS & USAGE SECTION

Apply liberally to affected area as needed.

Other Information:

OTHER SAFETY INFORMATION


■Store at room temperature 15°-30°C (68°-77°F)

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Lanolin Alcohol, Light Liquid Paraffin, Microcrystalline Wax, Paraffin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact PanelPrincipal Display and Drug Fact Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2609764petrolatum 44.3 % Topical OintmentPSN2
2609764petrolatum 0.443 MG/MG Topical OintmentSCD2
2609764petrolatum 44.28 % Topical OintmentSY2
2609764petrolatum 44.3 % Topical OintmentSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77338-014-232024-06-25C16284748780-11030e365-2ae6-111a-e063-dadaa90a10e2ASTONEA PHOR PETROLATUM 44.28%
77338-014-232024-01-30C16284748780-11030e365-2ae6-111a-e063-dadaa90a10e2ASTONEA PHOR PETROLATUM 44.28%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-014-23Tenderphor113 g in 1 TUBEOINTMENT1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-014TENDERPHOR (SKIN PROTECTANT) OINTMENT [ASTONEA LABS PRIVATE LIMITED]2Legacy NDC, 1 package rows20240627_e676a19c-c214-3307-e053-2a95a90a6e36.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77338-01477338-014-23

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICROCRYSTALLINE WAXXOF597Q3KYIACT
LIGHT MINERAL OILN6K5787QVPIACT
LANOLIN ALCOHOLS884C3FA9HEIACT
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UACTIB

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
1bbb307e-90cc-85d5-e063-6394a90aff22e676a19c-c214-3307-e053-2a95a90a6e362024-06-25WarningsExact identifier
spl id: 1bbb307e-90cc-85d5-e063-6394a90aff22
spl set id: e676a19c-c214-3307-e053-2a95a90a6e36

Reported adverse events (FAERS/openFDA)#

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