FDA.reportPublic FDA data

Balmex Diaper Rash

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 Diaper Rash
Active ingredientZinc Oxide
Label structure9 sections

Indications and uses

Helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps seal out wetness

Dosage and administration

change wet or soiled diapers promptly, cleanse the diaper area, and allow to dry apply cream 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
Zinc Oxide 11.3%Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • 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.

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

  • change wet or soiled diapers promptly, cleanse the diaper area, and allow to dry
  • apply cream 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 carton and or top of tube for lot number and expiration date

INACTIVE INGREDIENT SECTION

Inactive ingredients Beeswax, benzoic acid, dimethicone, fragrance, glycine soja (soybean) oil, magnesium aspartate, methylparaben, microcrystalline wax, mineral oil, oenothera biennis (evening primrose) seed extract, olea europea (olive) leaf extract, panthenol, potassium aspartate, potassium hydroxide, propylparaben, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water (245-230)

Questions?

OTC - QUESTIONS SECTION

1-833-389-9450

Dist. by: RANDOB LABS LTD. Box 440, Cornwall, NY 12518

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW LOOK-SAME PRODUCT

Balmex®
COMPLETE
PROTECTION™

Zinc Oxide

DIAPER RASH CREAM

Prevents & Heals

  • Protects against
    all 3 leading causes
    of diaper rash
  • Reduces rash in
    just 1 diaper change

Pediatrician Recommended

Advanced
Formula

NET WT 4 OZ (113 g)

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
967558Balmex 11.3 % Topical CreamPSN1
630923zinc oxide 11.3 % Topical CreamPSN1
967558zinc oxide 113 MG/ML Topical Cream [Balmex]SBD1
630923zinc oxide 113 MG/ML Topical CreamSCD1
967558Balmex 11.3 % Topical CreamSY1
967558Balmex 113 MG/ML Topical CreamSY1
967558Balmex Diaper Rash Cream StickSY1
630923zinc oxide 11.3 % Topical CreamSY1
630923ZNO 113 MG/ML Topical CreamSY1
967558ZNO 113 MG/ML Topical Cream [Balmex]SY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52412-400-02Balmex Diaper Rash1 in 1 CARTONCREAM11
52412-400-02Balmex Diaper Rash56 g in 1 TUBECREAM561
52412-400-04Balmex Diaper Rash113 g in 1 TUBECREAM1131
52412-400-04Balmex Diaper Rash1 in 1 CARTONCREAM11
52412-400-05Balmex Diaper Rash5.1 g in 1 PACKAGECREAM5.11
52412-400-16Balmex Diaper Rash453 g in 1 JARCREAM4531

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52412-400BALMEX DIAPER RASH (ZINC OXIDE) CREAM [RANDOB LABS,LTD.]1Current NDC, Legacy NDC, 6 package rows20181114_f202dd0e-7c61-4ea1-a5f6-e90898366ba3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52412-400-02GM - Gram52412-40006ff3824-4e22-4167-a4dc-878e0d05d4c212019-08-06
52412-400-04GM - Gram52412-400d8e1c508-907e-4ee1-87bb-6dc564de9fd612019-08-06
52412-400-16GM - Gram52412-4000810bdf1-9738-4b79-acef-f6474874ba5b12019-08-06

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52412-40052412-400-04, 52412-400-16, 52412-400-02, 52412-400-05

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
Yellow Wax2ZA36H0S2VIACT
Benzoic Acid8SKN0B0MIMIACT
Dimethicone 100RO266O364UIACT
Soybean Oil241ATL177AIACT
Magnesium Aspartate Anhydrous082H981FMAIACT
MethylparabenA2I8C7HI9TIACT
Microcrystalline WaxXOF597Q3KYIACT
Mineral OilT5L8T28FGPIACT
Oenothera Biennis76UI55V071IACT
Olea Europaea LeafMJ95C3OH47IACT
Dexpanthenol1O6C93RI7ZIACT
Potassium AspartateOC4598NZEQIACT
Potassium HydroxideWZH3C48M4TIACT
Propylene Glycol6DC9Q167V3IACT
PropylparabenZ8IX2SC1OHIACT
SarcosineZ711V88R5FIACT
Sorbitan Sesquioleate0W8RRI5W5AIACT
TocopherolR0ZB2556P8IACT
Water059QF0KO0RIACT
Sodium Cocoyl GlycinateXLU9KH03XMIACT
White Wax7G1J5DA97FIACT

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 Diaper RashZINC OXIDERandob Labs,Ltd.f202dd0e-7c61-4ea1-a5f6-e90898366ba32018-11-13WarningsExact identifier
ndc (package): 52412-400-02
ndc (package): 52412-400-05
ndc (package): 52412-400-16
ndc (package): 52412-400-04
ndc (product): 52412-400
ndc11 (package): 52412040004
ndc11 (package): 52412040016
ndc11 (package): 52412040002
ndc11 (package): 52412040005
spl id: 18af2fdd-d234-4675-afc6-e0bdd19cdbbd
spl set id: f202dd0e-7c61-4ea1-a5f6-e90898366ba3

Reported adverse events (FAERS/openFDA)#

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