FDA.reportPublic FDA data

Botao Baby Diaper Rash Cream

Manufacturer
Peer Pharm Ltd.
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:32:21

Label at a glance#

ProductBotao Baby Diaper Rash Cream
Active ingredientZINC OXIDE
Label structure7 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 and Soiled Diapers Promptly Cleanse the diaper area 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 Ingredients(in each 30 ml)

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12%

Purpose

OTC - PURPOSE SECTION

Sunscreen

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.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product,

OTC - WHEN USING SECTION

  • Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, call a poison control center or get medical help right  away.

Directions

DOSAGE & ADMINISTRATION SECTION

Change Wet and Soiled Diapers Promptly

Cleanse the diaper area

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 Ingredients

INACTIVE INGREDIENT SECTION

Coconut Alkanes, Cocos Nucifera (Virgin Coconut) Oil, Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Juice, Ricinus Communis (Castor) Seed Oil*, Ethyl Macadamiate, Shea Butter Ethyl Ester, Glycerin*, Polyglyceryl Esters, Polyhydroxystearic Acid, Citrus Aurantium Dulcis (Orange) Peel Wax, Simmondsia Chinensis (Jojoba) Seed Oil*, Jojoba Esters, Coco-Caprylate/Caprate, Copernicia Cerifera (Carnauba) Wax*, Butyrospermum Parkii (Shea Butter) Fruit*, Tocopherol (Vitamin E), Capric Acid, Silica, Disteardimonium Hectorite, Kaolin, Argania Spinosa (Argan) Kernel Oil, Rosa Canina Seed (Rosehip) Oil, Lavandula Angustifolia (Lavender) Oil, Olea Europaea (Olive) Oil, Origanum Vulgare (Oregano) Leaf Extract,
Tocopheryl Acetate, Basabolol, Malic Acid. May Contain: Iron Oxides.
*Certified Organic

Other Information

SPL UNCLASSIFIED SECTION

  • Store in room temparture
  • protect from freezing
  • may stain clothing

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TUBETUBEBOXBOX

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69435-1501-22024-01-31C16284748780-11030e365-2669-111a-e063-dadaa90a10e2Botao Baby Diaper Rash Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69435-1501-1Botao Baby Diaper Rash Cream70.8 g in 1 TUBE, WITH APPLICATORCREAM70.83
69435-1501-2Botao Baby Diaper Rash Cream1 in 1 BOXCREAM13

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69435-150169435-1501-1, 69435-1501-2

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
HEXASODIUM PHYTATEZBX50UG81VIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALGINIC ACID8C3Z4148WZIACT
ALOEV5VD430YW9IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
WATER059QF0KO0RIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
CETYL ALCOHOL936JST6JCNIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES0C9AC7D6XUIACT
RICINUS COMMUNIS SEED7EK4SFN1TXIACT
CASTOR OILD5340Y2I9GIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL 1-PHOSPHATE48G71659RBIACT
CHAMOMILEFGL3685T2XIACT
.BETA.-BISABOLOLLP618AV2EAIACT
XANTHAN GUMTTV12P4NEEIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ZINC OXIDESOI2LOH54ZACTIM

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
Botao Baby Diaper Rash CreamZINC OXIDEPeer Pharm Ltd.df60a70e-e6c0-41b3-e053-2995a90af1762026-01-12WarningsExact identifier
ndc (package): 69435-1501-1
ndc (package): 69435-1501-2
ndc (product): 69435-1501
ndc11 (package): 69435150101
ndc11 (package): 69435150102
spl id: 48300ffa-cb19-1829-e063-6294a90a3054
spl set id: df60a70e-e6c0-41b3-e053-2995a90af176

Reported adverse events (FAERS/openFDA)#

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