Caldesene Medicated Protecting Powder
FDA Label NDC 63736-306

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 Medicated Protecting (NDC 63736-306). 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

  • helps treat and prevent 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

  • avoid contact with eyes
  • keep away from 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 www.caldesene.com

Principal Display Panel

Caldesene ®
Medicated Protecting Powder

Cornstarch + Zinc Oxide
Fresh Scent
NET WT 5 OZ (142 g)

Principal Display Panelcaldesenemedicatedprotecting Powdercornstarch + Zinc Oxidefresh Scentnet Wt 5 Oz (142 G) (Caldesene Medicated Protecting Powder 01)

Principal Display Panelcaldesenemedicatedprotecting Powdercornstarch + Zinc Oxidefresh Scentnet Wt 5 Oz (142 G) (Caldesene Medicated Protecting Powder 01)

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