VITABATH BABY SOOTHING RELIEF DIAPER RASH- zinc oxide cream

Vitabath Baby Soothing Relief Diaper Rash by

Drug Labeling and Warnings

Vitabath Baby Soothing Relief Diaper Rash by is a Otc medication manufactured, distributed, or labeled by Vitabath Inc., Canadian Custom Packaging Comapany. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

When using this product avoid contact with eyes

STOP USE

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

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

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

INACTIVE INGREDIENT

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VITABATH BABY SOOTHING RELIEF DIAPER RASH 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73172-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73172-004-01	113 g in 1 TUBE; Type 0: Not a Combination Product	06/13/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/13/2019

Labeler - Vitabath Inc. (203461637)

Establishment
Name	Address	ID/FEI	Business Operations
Canadian Custom Packaging Comapany		207062514	manufacture(73172-004)