VITABATH BABY ECZEMA CARE MOISTURE- colloidal oatmeal cream

Vitabath Baby Eczema Care Moisture by

Drug Labeling and Warnings

Vitabath Baby Eczema Care Moisture by is a Otc medication manufactured, distributed, or labeled by Vitabath, Inc., Canadian Custom Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Colloidal Oatmeal 1% w/w

Purpose

Skin protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to Eczema Rashes

Warnings

For external use only.

When using this product

• Avoid contact with eyes

WHEN USING

When using this product do not get into eyes.

STOP USE

Stop use and ask a doctor if

• CONDITIONS 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 right away.

Directions

Apply as needed.

OTHER INFORMATION:

Remove quality seal Do not use if quality seal is broken For use on mild to moderate eczema or as directed by a physician Store at room temperature

Inactive Ingredients

Purified water
Glycerin
Distearyldimonium Chloride
Isopropyl Palmitate
Ricinus communis (Castor) Seed Oil
Cetyl Alcohol
Diheptyl Succinate
Benzyl Alcohol
Capryloyl Glycerin/Sebacic Acid Copolymer
Sodium Hydroxide
Steareth-20
Hydrogenated Castor Oil
Benzoic Acid
Dl-Panthenol
Beeswax
Dehydroacetic Acid
Sodium Chloride
Copernicia Cerifera (Carnauba) Wax
Tocopherol
Avena Sativa (Oat) Kernel Extract
Avena Sativa (Oat) Kernel Oil
Ceramide NP

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VITABATH BABY ECZEMA CARE MOISTURE 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73172-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
BENZOIC ACID (UNII: 8SKN0B0MIM)
PANTHENOL (UNII: WV9CM0O67Z)
YELLOW WAX (UNII: 2ZA36H0S2V)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TOCOPHEROL (UNII: R0ZB2556P8)
OAT (UNII: Z6J799EAJK)
OAT KERNEL OIL (UNII: 3UVP41R77R)
CERAMIDE NP (UNII: 4370DF050B)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
STEARETH-20 (UNII: L0Q8IK9E08)
CASTOR OIL (UNII: D5340Y2I9G)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
CARNAUBA WAX (UNII: R12CBM0EIZ)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73172-001-01	226 g in 1 TUBE; Type 0: Not a Combination Product	06/11/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	06/11/2019

Labeler - Vitabath, Inc. (203461637)

Establishment
Name	Address	ID/FEI	Business Operations
Canadian Custom Packaging		207062514	manufacture(73172-001)