KOALA KUBS DIAPER RASH CREAM- diaper rash cream cream 
Melaleuca, Inc.

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.

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Koala Kubs Diaper Rash Cream

Active Ingredients

Active Ingredients

Zinc Oxide USP 15%

Purpose

Purpose

Skin Protectant

Uses

Uses

When using this product

When using this product

Stop use and ask doctor if

Stop use and ask doctor if

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Directions

Other Information

Other Information

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

Purpose

Skin Protectant

Uses

Label

Tube

KOALA KUBS DIAPER RASH CREAM 
diaper rash cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-333
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE150 mg  in 88 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54473-333-0388 mL in 1 TUBE; Type 0: Not a Combination Product07/09/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/09/2021
Labeler - Melaleuca, Inc. (139760102)
Registrant - Melaleuca, Inc. (139760102)
Establishment
NameAddressID/FEIBusiness Operations
Melaleuca, Inc.079711683manufacture(54473-333)

Revised: 1/2023
Document Id: f205b04d-16da-02ba-e053-2a95a90a0108
Set id: c6b3b0dd-22a8-16f7-e053-2a95a90a51ea
Version: 2
Effective Time: 20230111
 
Melaleuca, Inc.