FDA.reportPublic FDA data

Baby Mantra Diaper Cream

Manufacturer
Renu Laboratories, LLC
Effective date
2025-04-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:59:04

Label at a glance#

ProductBaby Mantra Diaper Cream
Active ingredientZINC OXIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Zinc Oxide 10%

OTC - PURPOSE SECTION

Purpose

Skin Protectant

INDICATIONS & USAGE SECTION

Uses:

  • Helps treat and prevent diaper rash.
  • Protects chafed skin due to diaper rash and helps protect skin from wetness.
  • Helps prevent and temporarily protects chafed, chapped, cracked or wind-burned skin and lips.

WARNINGS SECTION

Warnings: 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

Do not use on:

  • deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

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 - DO NOT USE SECTION

Do not use on:

  • 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 right away.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Change wet and 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 anytime exposure to wet diaper

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Helianthus Annuus (Sunflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Beeswax (White), Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol (D-alpha), Aqua (Water), Glycerin

OTHER SAFETY INFORMATION

Store at room temperature

RECENT MAJOR CHANGES SECTION

For Indications and Usage section : Not a major change - We have only updated our Effective Date.

For Dosage and Administration section: Not a major change - we have only updated our Effective Date.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TUBE ARTWORK

TUBE ARTWORKTUBE ARTWORK

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199099zinc oxide 10 % Topical OintmentPSN2
199099zinc oxide 0.1 MG/MG Topical OintmentSCD2
199099zinc oxide 10 % Topical OintmentSY2
199099ZNO 0.1 MG/MG Topical OintmentSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-825-34Baby Mantra Diaper Cream100 mL in 1 TUBEOINTMENT1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-825BABY MANTRA DIAPER CREAM (ZINC OXIDE 10%) OINTMENT [RENU LABORATORIES, LLC]2Current NDC, 1 package rows20250416_0427bbc9-f4c0-0eb6-e063-6294a90a7199.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76348-82576348-825-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALMOND OIL66YXD4DKO9IACT
.ALPHA.-TOCOPHEROL, D-N9PR3490H9IACT
GLYCERINPDC6A3C0OXIACT
ZINC OXIDESOI2LOH54ZACTIB
JOJOBA OIL724GKU717MIACT
WHITE WAX7G1J5DA97FIACT
WATER059QF0KO0RIACT
ROSEMARYIJ67X351P9IACT
SUNFLOWER OIL3W1JG795YIIACT

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
Baby Mantra Diaper CreamZINC OXIDE 10%Renu Laboratories, LLC0427bbc9-f4c0-0eb6-e063-6294a90a71992025-04-14WarningsExact identifier
ndc (package): 76348-825-34
ndc (product): 76348-825
ndc11 (package): 76348082534
spl id: 32c47a66-a98d-817a-e063-6294a90ac7a3
spl set id: 0427bbc9-f4c0-0eb6-e063-6294a90a7199

Reported adverse events (FAERS/openFDA)#

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