Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash Cream

Manufacturer
Babo Botanicals, Inc.
Effective date
2024-05-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:11

Label at a glance#

ProductBabo Botanicals Sensitive Baby Fragrance Free Diaper Rash
Active ingredientZINC OXIDE
Label structure9 sections

Indications and uses

Helps treat and prevent diaper rash Protects minor skin irritation associated with diaper rash Helps seal out wetness

Dosage and administration

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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 25%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash
  • Protects minor skin irritation associated with diaper rash
  • 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 doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

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.

Other information

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics and surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

Butyrospermum Parkii (Shea) Butter*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Cocos Nucifera (Coconut) Oil*, Euphorbia Cerifera (Candelilla) Wax, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Vegetable Oil, Lecithin, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Rosmarinus Officinalis (Rosemary) Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Theobroma Cacao (Cocoa) Seed Butter*

*CERTIFIED ORGANIC INGREDIENTS

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-422-2987 M-F 9:00AM-5:00PM EST

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1125471zinc oxide 25 % Topical CreamPSN1
1125471zinc oxide 250 MG/ML Topical CreamSCD1
1125471zinc oxide 25 % Topical CreamSY1
1125471ZNO 250 MG/ML Topical CreamSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79265-8580-1Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash170 g in 1 JARCREAM1701

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79265-8580BABO BOTANICALS SENSITIVE BABY FRAGRANCE FREE DIAPER RASH (ZINC OXIDE) CREAM [BABO BOTANICALS, INC.]1Current NDC, 1 package rows20240601_186a9642-cd73-adfb-e063-6394a90a75c7.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79265-858079265-8580-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
Babo Botanicals Sensitive Baby Fragrance Free Diaper RashZINC OXIDEBabo Botanicals, Inc.186a9642-cd73-adfb-e063-6394a90a75c72024-05-14WarningsExact identifier
ndc (package): 79265-8580-1
ndc (product): 79265-8580
ndc11 (package): 79265858001
spl id: 186a9642-cd74-adfb-e063-6394a90a75c7
spl set id: 186a9642-cd73-adfb-e063-6394a90a75c7

Reported adverse events (FAERS/openFDA)#

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