Indications and uses
helps treats and prevents diaper rash temporarily protects and helps relieve minor skin irritation
Caldesene Baby Powder 636736-305
- 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 01:54:28
Label at a glance#
ProductCaldesene Baby
Active ingredientSTARCH, CORN, ZINC OXIDE
Label structure10 sections
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 ...
Contacts and useful links#
Websitewww.caldesene.com
www.caldesene.com
www.caldesene.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Caldesene®
Baby
Drug Facts
Active ingredients
Cornstarch 81%
Zinc Oxide 15%
Purpose
Skin Protectant
Skin Protectant
Uses
- helps treats and prevents diaper rash
- temporarily protects and helps relieve minor skin irritation
Warnings
For external use only.
Do not use
on broken skin.
When using this product
- do not get into eyes
- keep away from child's face and mouth to avoid breathing it
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
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
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
- Store at room temperature 15°–25°C (59°–77°F).
- See container bottom for lot number and expiration date.
Inactive ingredients
aloe vera gel, chamomile, fragrance, kaolin, tricalcium phosphate
Questions?
1-800-344-7239 or visit our website at www.caldesene.com
PRINCIPAL DISPLAY PANEL - 142 g Label
Caldesene®
Baby
Skin Protectant / Cornstarch Powder 81%
and Zinc Oxide 15%
NET WT 5 OZ (142 g)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1039057 | Caldesene Baby 81 % / 15 % Topical Powder | PSN | 6 |
| 1039054 | corn starch 81 % / zinc oxide 15 % Topical Powder | PSN | 6 |
| 1039057 | starch 0.81 MG/MG / zinc oxide 0.15 MG/MG Topical Powder [Caldesene] | SBD | 6 |
| 1039054 | starch 0.81 MG/MG / zinc oxide 0.15 MG/MG Topical Powder | SCD | 6 |
| 1039057 | Caldesene (starch 0.81 MG/MG / zinc oxide 0.15 MG/MG) Topical Powder | SY | 6 |
| 1039057 | Caldesene (starch 81 % / zinc oxide 15 % ) Topical Powder | SY | 6 |
| 1039054 | corn starch 81 % / zinc oxide 15 % Topical Powder | SY | 6 |
| 1039054 | Starch 0.81 MG/MG / ZNO 0.15 MG/MG Topical Powder | SY | 6 |
| 1039057 | Starch 0.81 MG/MG / ZNO 0.15 MG/MG Topical Powder [Caldesene] | SY | 6 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 63736-305-05 | Caldesene Baby | 142 g in 1 BOTTLE, DISPENSING | POWDER | 142 | 6 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Starch, Corn | ACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| Zinc Oxide | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| Starch, Corn | ACTIVE MOIETY | O8232NY3SJ | 1 | |
| Zinc Oxide | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| Kaolin | INACTIVE INGREDIENT | 24H4NWX5CO | 1 |
Products#
Every source-derived product name is available through these pages.
- Caldesene Baby
- Starch, Corn and Zinc Oxide
- STARCH, CORN
- ZINC OXIDE
- ALOE VERA LEAF
- CHAMOMILE
- KAOLIN
- TRICALCIUM PHOSPHATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63736-305 | 63736-305-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STARCH, CORN | O8232NY3SJ | ACTIB |
| ZINC OXIDE | SOI2LOH54Z | ACTIB |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| CHAMOMILE | FGL3685T2X | IACT |
| KAOLIN | 24H4NWX5CO | IACT |
| TRICALCIUM PHOSPHATE | K4C08XP666 | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Kaolin | KAOLIN | 24H4NWX5CO | POWDER / TOPICAL | 10056 mg | ||
| Kaolin | KAOLIN | 24H4NWX5CO | POWDER / TOPICAL | 10056 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Caldesene Baby | STARCH, CORN AND ZINC OXIDE | Insight Pharmaceuticals LLC | 9f12dee2-7afa-45e9-a729-0fd42bb77715 | 2026-04-22 | Warnings | 63736-305-05 63736-305 63736030505 8fd854c9-b6c2-4991-a592-4d102ca0ecf9 9f12dee2-7afa-45e9-a729-0fd42bb77715 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.