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

Key Label Information#

Active Ingredients And Purpose

Active Ingredients(in each 30 ml)

Zinc Oxide 12%

Uses

Uses

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

Warnings

warnings

For external use only.

Directions And Dosage

Directions

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.

Other Label Information

Inactive Ingredients

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

Package Labeling

Label Images#

33371_BOTAO_Diaper_Rash_CREAM_TUBE_FDA_07 (1)
33371_BOTAO_Diaper_Rash_CREAM_TUBE_FDA_07 (1)
33371_BOTAO_Diaper_Rash_CREAM_BOX_FDA_06
33371_BOTAO_Diaper_Rash_CREAM_BOX_FDA_06

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#

NDC Codes#

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

Ingredients#

Complete SPL Sections#

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredients(in each 30 ml)

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12%

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.

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

Source Document#

Source XML