FDA.reportPublic FDA data

Buddle Bottom Buddy Diaper Cream

Manufacturer
The Goodsprout Company LLC
Effective date
2024-12-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:48:16

Label at a glance#

ProductBuddle Bottom Buddy Diaper Cream
Active ingredientZINC OXIDE
Label structure9 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, 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.

Storage and handling

store at 20°C to 25°C (68°F to77°F) may stain clothing

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20%

Purpose

OTC - PURPOSE SECTION

Zinc oxide 20%...................Skin Protectant

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

OTC - WHEN USING SECTION

When using this product

  • do not get into eyes

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 - 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.

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

STORAGE AND HANDLING SECTION

  • store at 20°C to 25°C (68°F to77°F)
  • may stain clothing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

white petrolatum, water, anhydrous lanolin, zea mays (corn) starch, tridecyl trimellitate, glycerin, polyglyceryl-2 dipolyhydroxystearate, polyglyceryl-3 diisostearate, beeswax white, ceramide AP, ceramide NP, ceramide EOP, honey, alpha-glucan oligosaccharide, lactobacillus ferment, subtilisin, inulin, phytosphingosine, cetyI alcohol, lactic acid, xanthan gum, ethylhexylglycerin, benzyl alcohol, caprylyl glycol, carbomer, dehydroacetic acid, sodium chloride, sodium lauroyl lactylate, cholesterol

Questions?

OTC - QUESTIONS SECTION

Call 833-777-6880

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottom Buddy

buddle

Diaper Cream

Prevent diaper rash

Nourish baby's skin and normalize pH

ZINC OXIDE SKIN PROTECTANT

PROTECT

NET WT 4 OZ (113 g)

buddle Bottom Buddy Diaper Creambuddle Bottom Buddy Diaper Cream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
417425zinc oxide 20 % Topical CreamPSN3
417425zinc oxide 200 MG/ML Topical CreamSCD3
417425zinc oxide 20 % Topical CreamSY3
417425ZNO 200 MG/ML Topical CreamSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83178-102-04Buddle Bottom Buddy Diaper Cream113 g in 1 TUBECREAM1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83178-102BUDDLE BOTTOM BUDDY DIAPER CREAM (ZINC OXIDE) CREAM [THE GOODSPROUT COMPANY LLC]31 package rows20241225_0bdf463c-2139-9376-e063-6394a90a33ea.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83178-10283178-102-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETYL ALCOHOL936JST6JCNIACT
BENZYL ALCOHOLLKG8494WBHIACT
DEHYDROACETIC ACID2KAG279R6RIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
CERAMIDE APF1X8L2B00JIACT
SUBTILISIN0ZP13EBC5YIACT
LACTIC ACID33X04XA5ATIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SODIUM CHLORIDE451W47IQ8XIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
.ALPHA.-GLUCAN OLIGOSACCHARIDES95658MI3WIACT
WATER059QF0KO0RIACT
CHOLESTEROL97C5T2UQ7JIACT
XANTHAN GUMTTV12P4NEEIACT
LANOLIN7EV65EAW6HIACT
INULINJOS53KRJ01IACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CERAMIDE 15THT33P7X7IACT
LIMOSILACTOBACILLUS FERMENTUM2C1F12C6APIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
WHITE WAX7G1J5DA97FIACT
STARCH, CORNO8232NY3SJIACT
TRIDECYL TRIMELLITATEFY36J270ESIACT
GLYCERINPDC6A3C0OXIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
CERAMIDE NP4370DF050BIACT
HONEYY9H1V576FHIACT
ZINC OXIDESOI2LOH54ZACTIB

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
29f71288-9296-cd74-e063-6394a90a1f780bdf463c-2139-9376-e063-6394a90a33ea2024-12-23WarningsExact identifier
spl id: 29f71288-9296-cd74-e063-6394a90a1f78
spl set id: 0bdf463c-2139-9376-e063-6394a90a33ea

Reported adverse events (FAERS/openFDA)#

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