Active Ingredients
Active Ingredients
Zinc Oxide USP 15%
Koala Kubs Diaper Rash Cream
FDA Label NDC 54473-333
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Melaleuca, Inc. for the product Koala Kubs Diaper Rash Cream (NDC 54473-333). 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, when using this product, stop use and ask doctor if, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Purpose
Skin Protectant
Uses
Uses
- Helps treat and prevent diaper rash
- Protects chaffed skin due to diaper rash and helps seal out wetness
When Using This Product
When using this product
- do not get into eyes
Stop Use And Ask Doctor If
Stop use and ask 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 immediately.
Directions
Directions
- Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
- Apply cream liberally and as often as necessary with each diaper change and especially at bedtime or anytime when exposure to wet diapers may be prolonged.
Other Information
Other Information
- to open, twist off cap and remove quality seal
- do not use if quality seal is broken
- store at room temperature
Inactive Ingredients
Inactive Ingredients: water, decyl oleate, oleyl erucate, dicaprylyl ether, polyglyceryl-2 dipolyhydroxystearate, glycerin, polyglyceryl-3 diisostearate, magnesium stearate, sodium chloride, zinc stearate, benzyl alcohol, glycine soja (soybean) oil, sodium benzoate, ethylhexylglycerin, potassium sorbate, calendula officinalis (marigold) flower extract, tocopherol
Warnings
For external use only
Indications & Usage
Purpose
Skin Protectant
Uses
- Helps treat and prevent diaper rash
- Protects chafed skin due to diaper rash and helps seal out wetness
Label
Tube (Koala Kubs Diapercream 0520 O)
* Please review the disclaimer below.
