FDA.reportPublic FDA data

BALMEX MULTI-PURPOSE

Manufacturer
Randob Labs,Ltd. | KIK HOLDCO COMPANY INC.
Effective date
2018-11-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:15

Label at a glance#

ProductBALMEX MULTI-PURPOSE
Active ingredientPetrolatum
Label structure10 sections

Indications and uses

temporarily protects minor cuts scrapes burns temporarily protects and helps relieve chapped or cracked skin helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness 

Dosage and administration

apply as needed change wet or soiled diapers promptly, cleanse the diaper area, and allow to dry apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients Purpose

Petrolatum 51.1%

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects minor
    • cuts
    • scrapes
    • burns
  • temporarily protects and helps relieve chapped or cracked skin
  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness 

Warnings

WARNINGS SECTION

For external use only

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.

Do not use on

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply as needed
  • change wet or soiled diapers promptly, cleanse the diaper area, and allow to dry
  • apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged

Other information

SPL UNCLASSIFIED SECTION

  • do not use if quality seal is broken
  • see bottom of tube for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia farnesiana flower extract, allantoin, aloe barbadenis leaf extract, chamomilla recutita (matricaria) flower extract, cholecalciferol, cyclomethicone, dimethicone, fragrance, isopropyl myristate, isopropyl palmitate, lavandula angustifolia (lavender) extract, mineral oil, polyethylene, retinyl palmitate, rosmarinus officinalis (rosemary) extract, silica, tocopheryl acetate, zea mays (corn) oil (245-276)

Questions?

OTC - QUESTIONS SECTION

1-833-389-9450

SPL UNCLASSIFIED SECTION

Distributed by RANDOB LABS LTD.
Box 440, Cornwall, NY 12518

PRINCIPAL DISPLAY PANEL - 99 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW LOOK-SAME PRODUCT

Balmex®
MULTI-PURPOSE

HEALING OINTMENT
Skin Protectant-Petrolatum 51.1%

From diaper rash to
chapped, chafed skin

  • Heals, protects & soothes
  • 7 healing moisturizers
    plus Vitamin A & Vitamin D
  • Clear and easy to apply

Pediatrician Recommended

NET WT
3.5 OZ
(99 g)

Principal Display Panel - 99 g Tube Label
Principal Display Panel - 99 g Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1492071Balmex Healing 51.1 % Topical OintmentPSN1
1492066petrolatum 51.1 % Topical OintmentPSN1
1492071petrolatum 0.511 MG/MG Topical Ointment [Balmex Ointment]SBD1
1492066petrolatum 0.511 MG/MG Topical OintmentSCD1
1492071Balmex Ointment 0.511 MG/MG Topical OintmentSY1
1492071Balmex Ointment 51.1 % Topical OintmentSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52412-450-35BALMEX MULTI-PURPOSE99 g in 1 TUBEOINTMENT991

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52412-450BALMEX MULTI-PURPOSE (PETROLATUM) OINTMENT [RANDOB LABS,LTD.]1Current NDC, Legacy NDC, 1 package rows20181114_83a9ba1a-b708-47e2-a4a3-ef847e1bb792.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52412-450-35GM - Gram52412-4507c9078ba-8add-423c-89fe-8c45e628d4b212019-08-06

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
52412-45052412-450-35

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
Vachellia Farnesiana Flower8487B3MG6DIACT
Allantoin344S277G0ZIACT
Aloe Vera LeafZY81Z83H0XIACT
ChamomileFGL3685T2XIACT
Cholecalciferol1C6V77QF41IACT
Cyclomethicone 50THT5PCI0RIACT
Cyclomethicone 6XHK3U310BAIACT
Dimethicone 200RGS4T2AS00IACT
Isopropyl Myristate0RE8K4LNJSIACT
Isopropyl Palmitate8CRQ2TH63MIACT
Lavandula Angustifolia Subsp. Angustifolia Flowering Top9YT4B71U8PIACT
Mineral OilT5L8T28FGPIACT
High Density PolyethyleneUG00KM4WR7IACT
Vitamin A Palmitate1D1K0N0VVCIACT
RosemaryIJ67X351P9IACT
Silicon DioxideETJ7Z6XBU4IACT
.alpha.-tocopherol Acetate, Dl-WR1WPI7EW8IACT
Corn Oil8470G57WFMIACT

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
BALMEX MULTI-PURPOSEPETROLATUMRandob Labs,Ltd.83a9ba1a-b708-47e2-a4a3-ef847e1bb7922018-11-13WarningsExact identifier
ndc (package): 52412-450-35
ndc (product): 52412-450
ndc11 (package): 52412045035
spl id: 8460153a-29a3-4b1e-8e15-c1be1176e97c
spl set id: 83a9ba1a-b708-47e2-a4a3-ef847e1bb792

Reported adverse events (FAERS/openFDA)#

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