Warnings
Warnings
For external use only.
Diaper Rash Cream
FDA Label NDC 87781-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Foshan Desha Biotechnology Co., Ltd. for the product Diaper Rash Cream (NDC 87781-001). 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 warnings, inactive ingredient, indications & usage, otc - keep out of reach of children, dosage & administration, recent major changes, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
WATER
BUTYLENE GLYCOL
GLYCERIN
CAPRYLIC/CAPRIC TRIGLYCERIDE
CETEARYL ALCOHOL
HYDROGENATED COCONUT OIL
ISOHEXADECANE
DIMETHICONE
GLYCERYL STEARATE
PEG-100 STEARATE
PHENOXYETHANOL
CETEARYL GLUCOSIDE
TOCOPHERYL ACETATE
CITRIC ACID
CAPRYLYL GLYCOL
ETHYLHEXYLGLYCERIN
LAVANDULA HYBRIDA OIL
BISABOLOL
ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT
CHRYSANTHELLUM INDICUM EXTRACT
PORTULACA OLERACEA (PURSLANE) EXTRACT
SODIUM POLYACRYLATE
C11 13 ISOPARAFFIN
C13 14 ISOPARAFFIN
TRIDECETH 6
DISODIUM EDTA
Indications & Usage
Uses
Helps treat and prevent diaper rash
Protects chafed skin and minor irritation associated with diaper rash
Helps seal out wetness
When using this product
Avoid contact with eyes during use.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of infants. If accidentally ingested, seek medical attention immediately or contact a poison control center.
Dosage & Administration
Directions
Change wet or soiled diapers promptly. Clean the diaper area and let it dry. Apply diaper cream as needed during each diaper change, especially before bedtime or when in contact with a wet diaper for a long time.
Recent Major Changes
Uses
Helps treat and prevent diaper rash
Protects chafed skin and minor irritation associated with diaper rash
Helps seal out wetness
When using this product
Avoid contact with eyes during use.
Package Label.Principal Display Panel
1 (Wps)
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