Mustela® Diaper Rash Cream 1 2 3

Mustela® Diaper Rash Cream 1 2 3
SPL v7
SPL
SPL Set ID 163f388e-849d-4b7e-93c1-9045d77a9ec2
Route
TOPICAL
Published
Effective Date 2018-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (9.9 g)
Inactive Ingredients
Sunflower Oil Levulinic Acid Magnesium Sulfate, Unspecified Form Avocado Avocado Oil Polyglyceryl-2 Dipolyhydroxystearate Polyglyceryl-3 Diisostearate Propylene Carbonate Sodium Levulinate Stearalkonium Hectorite 4,4-dimethyloxazolidine Water Yellow Wax Medium-chain Triglycerides Capryloyl Glycine Caprylyl Glycol Coco-caprylate/caprate Ethyl Linoleate Glycerin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-01-09

Description

Zinc Oxide 9.9 %

Purpose

skin protectant


Medication Information

Purpose

skin protectant

Description

Zinc Oxide 9.9 %

Uses
  • Helps treat and prevent diaper rash
  • Protects chafed skin associated with diaper rash
  • Helps seal out wetness
Warnings

For external use only.

Directions
  • Change wet and soiled diapers promptly. Cleanse the diaper area and allow to dry.
  • Apply cream liberally and as often as necessary and with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Active Ingredient

Zinc Oxide 9.9 %

Other Information
  • You may report serious side effects to the phone number provided below or to Expanscience Laboratories Inc. dba Mustela, 60 E. 56th St. 6th Floor, New York, New York 10022, USA.
  • PE plastic tube ensures proper product conservation and facilitates daily use.
Product Packaging

Company Information

Distributed in USA by



Expanscience Laboratories



dba Mustela, New York, NY 10022, USA

Inactive Ingredients

Water, Caprylic/capric Triglyceride, Coco-caprylate/caprate, Polyglyceryl-2-dipolyhydroxystearate, Glycerin, Beeswax, Persea Gratissima (Avocado) Oil, Polyglyceryl-3 Diisostearate, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Ethyl Linoleate, Persea Gratissima (Avocado) Fruit Extract, Magnesium Sulfate, Stearalkonium Hectorite, Levulinic Acid, Caprylyl Glycol, Capryloyl Glycine, Sodium Levulinate, Undecyl Dimethyl Oxazoline, Propylene Carbonate

Questions Or Comments ?

Call toll free 1-800-422-2987 Monday-Friday 9:00am-5:00pm EST

When Using This Product
  • do not get into eyes

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last more than seven days
  • symptoms 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 right away.


Structured Label Content

Uses
  • Helps treat and prevent diaper rash
  • Protects chafed skin associated with diaper rash
  • Helps seal out wetness
Purpose

skin protectant

Warnings

For external use only.

Directions
  • Change wet and soiled diapers promptly. Cleanse the diaper area and allow to dry.
  • Apply cream liberally and as often as necessary and with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Active Ingredient (Active ingredient)

Zinc Oxide 9.9 %

Other Information (Other information)
  • You may report serious side effects to the phone number provided below or to Expanscience Laboratories Inc. dba Mustela, 60 E. 56th St. 6th Floor, New York, New York 10022, USA.
  • PE plastic tube ensures proper product conservation and facilitates daily use.
Product Packaging

Company Information (Company information)

Distributed in USA by



Expanscience Laboratories



dba Mustela, New York, NY 10022, USA

Inactive Ingredients (Inactive ingredients)

Water, Caprylic/capric Triglyceride, Coco-caprylate/caprate, Polyglyceryl-2-dipolyhydroxystearate, Glycerin, Beeswax, Persea Gratissima (Avocado) Oil, Polyglyceryl-3 Diisostearate, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Ethyl Linoleate, Persea Gratissima (Avocado) Fruit Extract, Magnesium Sulfate, Stearalkonium Hectorite, Levulinic Acid, Caprylyl Glycol, Capryloyl Glycine, Sodium Levulinate, Undecyl Dimethyl Oxazoline, Propylene Carbonate

Questions Or Comments ? (Questions or comments ?)

Call toll free 1-800-422-2987 Monday-Friday 9:00am-5:00pm EST

When Using This Product (When using this product)
  • do not get into eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms last more than seven days
  • symptoms 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 right away.


Advanced Ingredient Data


Raw Label Data

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