FDA.reportPublic FDA data

Caldesene Medicated Protecting Powder

Manufacturer
Insight Pharmaceuticals LLC
Effective date
2026-04-22
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:54:35

Label at a glance#

ProductCaldesene Medicated Protecting
Active ingredientSTARCH, CORN, ZINC OXIDE
Label structure10 sections

Indications and uses

helps treat and prevents diaper rash temporarily protects and helps relieve minor skin irritation

Dosage and administration

For diaper rash change wet or soiled diapers 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 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 For minor skin irritations smooth on ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Cornstarch 81%

Zinc Oxide 15%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • helps treat and prevents diaper rash
  • temporarily protects and helps relieve minor skin irritation

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on broken skin.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes
  • keep away from face and mouth to avoid breathing it

Stop use and ask a 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For diaper rash

  • change wet or soiled diapers 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 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

For minor skin irritations

  • smooth on powder to protect irritated and chafed skin. Apply as needed.

Other information 

OTHER SAFETY INFORMATION

Store at room temperature 15-25°C (59-77°F). 

See container bottom for lot number and expiration date.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera gel, chamomile, fragrance, kaolin, tricalcium phosphate

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Caldesene ®
by Boudreaux’s Butt Paste ®

Medicated Protecting Powder
Skin protectant / cornstarch 81%

and zinc oxide 15%




NET WT 5 OZ (142 g)

PRINCIPAL DISPLAY PANEL Caldesene ® by Boudreaux’s Butt Paste ® Medicated Protecting Powder Skin protectant / cornstarch 81% and zinc oxide 15% NET WT 5 OZ (142 g)PRINCIPAL DISPLAY PANEL Caldesene ® by Boudreaux’s Butt Paste ® Medicated Protecting Powder Skin protectant / cornstarch 81% and zinc oxide 15% NET WT 5 OZ (142 g)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039057Caldesene Baby 81 % / 15 % Topical PowderPSN6
1039054corn starch 81 % / zinc oxide 15 % Topical PowderPSN6
1039057starch 0.81 MG/MG / zinc oxide 0.15 MG/MG Topical Powder [Caldesene]SBD6
1039054starch 0.81 MG/MG / zinc oxide 0.15 MG/MG Topical PowderSCD6
1039057Caldesene (starch 0.81 MG/MG / zinc oxide 0.15 MG/MG) Topical PowderSY6
1039057Caldesene (starch 81 % / zinc oxide 15 % ) Topical PowderSY6
1039054corn starch 81 % / zinc oxide 15 % Topical PowderSY6
1039054Starch 0.81 MG/MG / ZNO 0.15 MG/MG Topical PowderSY6
1039057Starch 0.81 MG/MG / ZNO 0.15 MG/MG Topical Powder [Caldesene]SY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-306-01Caldesene Medicated Protecting142 g in 1 BOTTLEPOWDER1426

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63736-30663736-306-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, CORNO8232NY3SJACTIB
ZINC OXIDESOI2LOH54ZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CHAMOMILEFGL3685T2XIACT
KAOLIN24H4NWX5COIACT
TRICALCIUM PHOSPHATEK4C08XP666IACT

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
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
ndc (package): 63736-306-01
ndc (product): 63736-306
ndc11 (package): 63736030601
spl id: 954623a3-77db-4ff4-8b50-cbe143a16955
spl set id: ffc92a0f-a7cf-4a46-b2f1-089df2bbb96b

Reported adverse events (FAERS/openFDA)#

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