NDC | 63736-306-01 |
Set ID | ffc92a0f-a7cf-4a46-b2f1-089df2bbb96b |
Category | HUMAN OTC DRUG LABEL |
Packager | Insight Pharmaceuticals LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART347 |
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
- Warnings
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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
- change wet or soiled diapers promptly
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CALDESENE MEDICATED PROTECTING
cornstarch and zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-306 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength STARCH, CORN (UNII: O8232NY3SJ) (STARCH, CORN - UNII:O8232NY3SJ) STARCH, CORN 115 g in 142 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 21 g in 142 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CHAMOMILE (UNII: FGL3685T2X) KAOLIN (UNII: 24H4NWX5CO) TRICALCIUM PHOSPHATE (UNII: K4C08XP666) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63736-306-01 142 g in 1 BOTTLE; Type 0: Not a Combination Product 07/15/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 07/15/2017 Labeler - Insight Pharmaceuticals LLC (055665422)