Koala Kubs Diaper Rash Cream

Koala Kubs Diaper Rash Cream
SPL v3
SPL
SPL Set ID c6b3b0dd-22a8-16f7-e053-2a95a90a51ea
Route
TOPICAL
Published
Effective Date 2021-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (0.154 mL)
Inactive Ingredients
Ethylhexylglycerin Potassium Sorbate Calendula Officinalis Flower Water Decyl Oleate Tocopherol Polyglyceryl-2 Dipolyhydroxystearate Soybean Oil Zinc Stearate Oleyl Erucate Sodium Benzoate Glycerin Dicaprylyl Ether Polyglyceryl-3 Diisostearate Magnesium Stearate Sodium Chloride Benzyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-09

Description

Active Ingredients Zinc Oxide USP 15%

Purpose

Purpose Skin Protectant


Medication Information

Indications and Usage

Purpose

Skin Protectant

Uses

  • Helps treat and prevent diaper rash
  • Protects chafed skin due to diaper rash and helps seal out wetness
Purpose

Purpose

Skin Protectant

Description

Active Ingredients Zinc Oxide USP 15%

Uses

Uses

  • Helps treat and prevent diaper rash
  • Protects chaffed skin due to diaper rash and helps seal out wetness
Label

Warnings

For external use only

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
Active Ingredients

Active Ingredients

Zinc Oxide USP 15%

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

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.


Structured Label Content

Uses

Uses

  • Helps treat and prevent diaper rash
  • Protects chaffed skin due to diaper rash and helps seal out wetness
Label

Indications and Usage (34067-9)

Purpose

Skin Protectant

Uses

  • Helps treat and prevent diaper rash
  • Protects chafed skin due to diaper rash and helps seal out wetness
Purpose

Purpose

Skin Protectant

Warnings

For external use only

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
Active Ingredients

Active Ingredients

Zinc Oxide USP 15%

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

When Using This Product (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)

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 (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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