Mustela Vitamin Barrier

Dosage form: lotion
Ingredients: Zinc Oxide 5.5g in 55g
Labeler: Expanscience Laboratoires d/b/a Mustela
NDC Code: 64768-2911

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.

mustela®
Vitamin
barrier cream

Drug Facts

Active ingredient

Zinc oxide 10 %

Purpose

skin protectant

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

Warnings

For external use only

When using this product

  • avoid contact with eyes

Stop use and ask a doctor if

  • conditions worsen
  • symptoms last more than seven days
  • symptoms clear up and occur again within a few days

Keep out of the reach of children if swallowed, get medical help or contact a Poison Control Center right away.

Directions

Change wet and soiled diapers promptly. Cleanse the diaper area and allow to dry. Apply cream liberally, as often as necessary, with each diaper change, especially at bedtime or before any prolonged exposure to wet diapers.

Alumino-plastic tube ensures proper product conservation and facilitates daily use.

Inactive ingredients

WATER, MINERAL OIL, METHYL GLUCOSE DIOLEATE, PROPYLENE GLYCOL DIETHYLHEXANOATE, PEG-45/DODECYL GLYCOL COPOLYMER, TITANIUM DIOXIDE, GLYCERIN, CERESIN, 1,2-HEXANEDIOL, ETHYL LINOLEATE, PEG-8, BUTYROSPERMUM PARKII (SHEA) BUTTER, PANTHENOL, GLYCERYL CAPRYLATE, FRAGRANCE, CAPRYLYL GLYCOL, MAGNESIUM SULFATE, SORBIC ACID, SODIUM POLYACRYLATE, CITRIC ACID.

Serious side effects?

Call 1-800 422-2987

www.mustelausa.com

PRINCIPAL DISPLAY PANEL - 55g Tube Carton

mustela®

bébé

Vitamin
barrier cream

10% Zinc Oxide

Diaper rash cream
skin protectant

Free
paraben, phthalate,
phenoxyethanol

HYPOALLERGENIC
TESTED UNDER DERMATOLOGICAL CONTROL

55g - 1.94 OZ

EXPANSCIENCE®
LABORATOIRES

MUSTELA   VITAMIN BARRIER
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64768-2911
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (Zinc Oxide) Zinc Oxide5.5 g  in 55 g
Inactive Ingredients
Ingredient NameStrength
Water 
Mineral Oil 
Propylene Glycol Diethylhexanoate 
PEG-120 Methyl Glucose Dioleate 
Titanium Dioxide 
Glycerin 
Ethyl Linoleate 
Shea Butter 
Polyoxyl 8 Stearate 
Panthenol 
Potassium Sorbate 
Magnesium Sulfate, Unspecified 
Methylparaben 
Caprylyl Glycol 
Propylparaben 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:64768-2911-11 TUBE (TUBE) in 1 CARTON
155 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34707/19/2010
Labeler - Expanscience Laboratoires d/b/a Mustela (181191057)
Establishment
NameAddressID/FEIOperations
Expanscience Laboratoires d/b/a Mustela391128493MANUFACTURE

Revised: 07/2010
 
Expanscience Laboratoires d/b/a Mustela

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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