VITABATH BABY SOOTHING RELIEF DIAPER RASH- zinc oxide cream 
Vitabath 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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Vitabath Baby Soothing Relief Diaper Rash Cream

Active Ingredients

Zinc Oxide 14% w/w

Purpose

Skin protectant

Uses

Uses: •helps treat and prevent diaper rash •protects
chafed skin due to diaper rash •helps seal out wetness

Warnings

For external use only.

When using this product •avoid contact with eyes

When using this product •avoid contact with eyes

Stop use and ask a doctor if •condition worsens or
does not improve within 7 days.

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

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

Other Information: •Remove quality seal. •Do not use if
quality seal is broken.

Inactive Ingredients: Helianthus Annuus (Sunflower)
Seed Oil, Beeswax white, Ricinus Communis (Castor)
Seed Oil, Butyrospermum Parkii (Shea) Butter, Cocos
Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit
Oil, Tocopherol, Salvia Sclarea (Clary) Oil, Simmondsia
Chinensis (Jojoba) Seed Oil, Vitis Vinifera (Grape)
Seed Oil, Avena Sativa (Oat) Kernel Oil, Calophyllum
Inophyllum Seed Oil.

Questions? Call toll-free 1-888-673-3377

Tube Label

VITABATH BABY SOOTHING RELIEF DIAPER RASH 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73172-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TAMANU OIL (UNII: JT3LVK84A1)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
WHITE WAX (UNII: 7G1J5DA97F)  
CASTOR OIL (UNII: D5340Y2I9G)  
SHEA BUTTER (UNII: K49155WL9Y)  
OAT KERNEL OIL (UNII: 3UVP41R77R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CLARY SAGE OIL (UNII: 87L0D4U3M0)  
JOJOBA OIL (UNII: 724GKU717M)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73172-004-01113 g in 1 TUBE; Type 0: Not a Combination Product06/13/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34706/13/2019
Labeler - Vitabath Inc. (203461637)
Establishment
NameAddressID/FEIBusiness Operations
Canadian Custom Packaging Comapany207062514manufacture(73172-004)

Revised: 6/2019
Document Id: 8b3a3875-de21-306f-e053-2a95a90a7ab8
Set id: 8b3a3b17-67dd-7a13-e053-2995a90a099c
Version: 1
Effective Time: 20190613
 
Vitabath Inc.