Label: KOALA KUBS DIAPER RASH CREAM- diaper rash cream cream
- NDC Code(s): 54473-333-03
- Packager: Melaleuca, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 11, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- When using this product
- Stop use and ask doctor if
- Keep out of reach of children
- Directions
- Other Information
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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
- INDICATIONS & USAGE
- Label
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INGREDIENTS AND APPEARANCE
KOALA KUBS DIAPER RASH CREAM
diaper rash cream creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-333 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 150 mg in 88 mL Inactive Ingredients Ingredient Name Strength ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.154 mL in 88 mL POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.1408 mL in 88 mL CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) 0.011 mL in 88 mL WATER (UNII: 059QF0KO0R) 44.4576 mL in 88 mL DECYL OLEATE (UNII: ZGR06DO97T) 8.8 mL in 88 mL TOCOPHEROL (UNII: R0ZB2556P8) 0.00132 mL in 88 mL POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) 2.64 mL in 88 mL SOYBEAN OIL (UNII: 241ATL177A) 0.42856 mL in 88 mL ZINC STEARATE (UNII: H92E6QA4FV) 0.88 mL in 88 mL OLEYL ERUCATE (UNII: 753W099NQ6) 4.4 mL in 88 mL SODIUM BENZOATE (UNII: OJ245FE5EU) 0.2816 mL in 88 mL GLYCERIN (UNII: PDC6A3C0OX) 2.64 mL in 88 mL DICAPRYLYL ETHER (UNII: 77JZM5516Z) 4.4 mL in 88 mL POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) 1.76 mL in 88 mL MAGNESIUM STEARATE (UNII: 70097M6I30) 1.76 mL in 88 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 1.32 mL in 88 mL BENZYL ALCOHOL (UNII: LKG8494WBH) 0.72512 mL in 88 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54473-333-03 88 mL in 1 TUBE; Type 0: Not a Combination Product 07/09/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 07/09/2021 Labeler - Melaleuca, Inc. (139760102) Registrant - Melaleuca, Inc. (139760102) Establishment Name Address ID/FEI Business Operations Melaleuca, Inc. 079711683 manufacture(54473-333)
