FDA.reportPublic FDA data

Medicated Cornstarch Baby Powder

Manufacturer
Davion, Inc.
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:29:30

Label at a glance#

ProductMedicated Cornstarch Baby Powder
Active ingredientSTARCH, CORN, ZINC OXIDE, KAOLIN
Label structure7 sections

Indications and uses

Prevents chafed skin and reduces minor skin irritations due to diaper rash Helps protect from wetness

Dosage and administration

Babies: Change wet and soiled diaper promptly, cleanse the diaper area and allow to dry.  Apply powder liberally as often as necessary, with each diaper change, especially at bedtime, or anytime when exposure to wet diapers may be prolonged.  Apply powder close to the body away from child's face.  Carefully shake the powder into the diaper or into the hand and apply to diaper area.   Adults and children 2 years an...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Corn Starch 79%

Kaolin 4%

Zinc Oxide 15%

Purposes

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Prevents chafed skin and reduces minor skin irritations due to diaper rash
  • Helps protect from wetness

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes
  • Do not use on broken skin
  • Keep powder away from child's face to avoid inhalation which can cause breathing problems
Stop use and ask a doctor if

OTC - STOP USE SECTION

  • If conditions worsen or symptoms do not get better within 7 days
Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Babies: Change wet and soiled diaper promptly, cleanse the diaper area and allow to dry.  Apply powder liberally as often as necessary, with each diaper change, especially at bedtime, or anytime when exposure to wet diapers may be prolonged.  Apply powder close to the body away from child's face.  Carefully shake the powder into the diaper or into the hand and apply to diaper area.  

Adults and children 2 years and older: apply freely up to 3 or 4 times daily.  For best results, dry skin thoroughly before applying.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Fragrance, Silica

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medicated Cornstarch Baby PowderMedicated Cornstarch Baby Powder

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1361201cornstarch 79 % / kaolin 4 % / zinc oxide 15 % Topical PowderPSN4
1361201corn starch 0.79 MG/MG / kaolin 0.04 MG/MG / zinc oxide 0.15 MG/MG Topical PowderSCD4
1361201corn starch 0.79 MG/MG / Kaolin 0.04 MG/MG / ZNO 0.15 MG/MG Topical PowderSY4
1361201cornstarch 79 % / kaolin 4 % / zinc oxide 15 % Topical PowderSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42669-231-042024-02-28C16284748780-11030e365-312c-111a-e063-dadaa90a10e2Medicated Cornstarch Baby Powder
42669-231-042024-01-30C16284748780-11030e365-312c-111a-e063-dadaa90a10e2Medicated Cornstarch Baby Powder

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42669-231-04Medicated Cornstarch Baby Powder113 g in 1 BOXPOWDER1134

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42669-23142669-231-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJACTIB
ZINC OXIDESOI2LOH54ZACTIB
KAOLIN24H4NWX5COACTIB

Source Document#

Source XML · Source PDF

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
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
ndc (package): 42669-231-04
ndc (product): 42669-231
ndc11 (package): 42669023104
spl id: 8e64a51a-f760-498c-81d2-40be7ff55478
spl set id: e39032d1-c8cd-4a41-af10-126970b8ad38

Reported adverse events (FAERS/openFDA)#

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