Caldesene Baby Powder
FDA Label NDC 63736-305

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Insight Pharmaceuticals Llc for the product Caldesene Baby (NDC 63736-305). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Cornstarch 81%

Zinc Oxide 15%

Purpose

Skin Protectant

Skin Protectant

Uses

  • treats and prevents diaper rash
  • protects minor skin irritation

Warnings

For external use only

Do Not Use

on broken skin

When Using This Product

  • avoid contact with 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

Other Information

Store at room temperature 15°–25°C (59°–77°F). See container for lot number and expiration date.

Inactive Ingredients

aloe vera, chamomile, fragrance, kaolin, tricalcium phosphate

Questions?

1-800-344-7239 www.caldesene.com

Product packaged by weight not volume.

Principal Display Panel - 142 G Label

Caldesene® 
Baby

Cornstarch Powder
with Zinc Oxide

NET WT 5 OZ (142 g)

Principal Display Panel (142 g LabelCaldesene® BabyCornstarch Powderwith Zinc OxideNET WT 5 OZ (142 g))

Principal Display Panel (142 g LabelCaldesene® BabyCornstarch Powderwith Zinc OxideNET WT 5 OZ (142 g))

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