FDA.reportPublic FDA data

Balmex Diaper Rash Cream

Manufacturer
Randob Labs, LTD | Derma Care Research Labs
Effective date
2024-12-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:43:48

Label at a glance#

ProductBalmex Diaper Rash
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 11.3%

OTC - PURPOSE SECTION

Skin Protectant

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only.

When using this product do not get into eyes.

Stop use and ask a doctor if 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

If swallowed, seek medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Change wet and 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 anytime when exposure to wet diapers may be prolonged.

INACTIVE INGREDIENT SECTION

Beeswax, benzoic acid, dimethicone, glycine soja (soybean) oil, magnesium aspartate, microcrystalline wax, mineral oil, oenothera biennis (evening primrose) seed extract, olea europae (olive) leaf extract, panthenol, Peruvian balsam, Phenoxyethanol, potassium aspartate, potassium hydroxide, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
967558Balmex 11.3 % Topical CreamPSN3
630923zinc oxide 11.3 % Topical CreamPSN3
967558zinc oxide 113 MG/ML Topical Cream [Balmex]SBD3
630923zinc oxide 113 MG/ML Topical CreamSCD3
967558Balmex 11.3 % Topical CreamSY3
967558Balmex 113 MG/ML Topical CreamSY3
967558Balmex Diaper Rash Cream StickSY3
630923zinc oxide 11.3 % Topical CreamSY3
630923ZNO 113 MG/ML Topical CreamSY3
967558ZNO 113 MG/ML Topical Cream [Balmex]SY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
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
52412-285-02Balmex Diaper Rash1 in 1 CARTONCREAM13
52412-285-02Balmex Diaper Rash56 g in 1 TUBECREAM563
52412-285-03Balmex Diaper Rash85 g in 1 TUBECREAM853
52412-285-03Balmex Diaper Rash1 in 1 CARTONCREAM13
52412-285-04Balmex Diaper Rash1 in 1 CARTONCREAM13
52412-285-04Balmex Diaper Rash113 g in 1 TUBECREAM1133
52412-285-12Balmex Diaper Rash340 g in 1 JARCREAM3403
52412-285-16Balmex Diaper Rash453 g in 1 JARCREAM4533

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52412-285BALMEX DIAPER RASH (ZINC OXIDE 11.3%) CREAM [RANDOB LABS, LTD]3Current NDC, 8 package rows20241217_f7f7a89d-d4e0-9faa-e053-6294a90aaf7b.zip

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
52412-28552412-285-16, 52412-285-12, 52412-285-04, 52412-285-02, 52412-285-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOIC ACID8SKN0B0MIMIACT
DIMETHICONE 3502Y53S6ATLUIACT
SOYBEAN OIL241ATL177AIACT
MAGNESIUM ASPARTATER17X820ROLIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
MINERAL OILT5L8T28FGPIACT
EVENING PRIMROSE OIL3Q9L08K71NIACT
OLEA EUROPAEA LEAFMJ95C3OH47IACT
PANTHENOLWV9CM0O67ZIACT
BALSAM PERU8P5F881OCYIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM ASPARTATEOC4598NZEQIACT
ZINC OXIDESOI2LOH54ZACTIB
POTASSIUM HYDROXIDEWZH3C48M4TIACT
SARCOSINEZ711V88R5FIACT
COCO ACID CHLORIDESR7N8Y0XMX7IACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
SYNTHETIC BEESWAX08MNR5YE2RIACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
YELLOW WAX2ZA36H0S2VIACT

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 OXIDE 11.3%Randob Labs, LTDf7f7a89d-d4e0-9faa-e053-6294a90aaf7b2024-12-15WarningsExact identifier
ndc (package): 52412-285-04
ndc (package): 52412-285-12
ndc (package): 52412-285-03
ndc (package): 52412-285-02
ndc (package): 52412-285-16
ndc (product): 52412-285
ndc11 (package): 52412028502
ndc11 (package): 52412028503
ndc11 (package): 52412028504
ndc11 (package): 52412028512
ndc11 (package): 52412028516
spl id: 29577ef9-f215-1dc6-e063-6394a90a44ab
spl set id: f7f7a89d-d4e0-9faa-e053-6294a90aaf7b

Reported adverse events (FAERS/openFDA)#

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