KOALA KUBS DIAPER RASH CREAM- diaper rash cream cream

Koala Kubs Diaper Rash Cream by

Drug Labeling and Warnings

Koala Kubs Diaper Rash Cream by is a Otc medication manufactured, distributed, or labeled by Melaleuca, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Active Ingredients

Zinc Oxide USP 15%

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

INGREDIENTS AND APPEARANCE

KOALA KUBS DIAPER RASH CREAM 
diaper rash cream cream

Product 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 Drug	M016	07/09/2021

Labeler - Melaleuca, Inc. (139760102)

Registrant - Melaleuca, Inc. (139760102)

Establishment
Name	Address	ID/FEI	Business Operations
Melaleuca, Inc.		079711683	manufacture(54473-333)