VITABATH BABY ECZEMA CARE INTENSIVE BALM- colloidal oatmeal cream

Vitabath Baby Eczema Care Intensive Balm by

Drug Labeling and Warnings

Vitabath Baby Eczema Care Intensive Balm 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

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 do not get into eyes.

STOP USE

Stop use and ask a doctor if condition 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

Directions: Apply as needed.

OTHER INFORMATION

Other Information: Remove quality seal. Do not use if quality seal is broken. Protect from
excessive heat (40°C/104°F).

Inactive Ingredients

Purified Water
Glycerin
Cetearyl Alcohol
Isopropyl Palmitate
Cetyl Alcohol
Caprylic/Capric Triglyceride
Sodium Stearoyl Glutamate
Stearic Acid
Benzyl Alcohol
Diheptyl Succinate
Potassium Phosphate Monobasic
Capryloyl Glycerin/Sebacic Acid Copolymer
Citric Acid
Sodium Hydroxide
Benzoic Acid
Dehydroacetic Acid
Tocopherol
Avena Sativa (Oat) Kernel Extract
Avena Sativa (Oat) Kernel Oil
Ceramide NP
Dipotassium Phosphate

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VITABATH BABY ECZEMA CARE INTENSIVE BALM 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73172-003
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
TOCOPHEROL (UNII: R0ZB2556P8)
OAT KERNEL OIL (UNII: 3UVP41R77R)
BENZOIC ACID (UNII: 8SKN0B0MIM)
OAT (UNII: Z6J799EAJK)
CERAMIDE NP (UNII: 4370DF050B)
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CETYL ALCOHOL (UNII: 936JST6JCN)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
STEARIC ACID (UNII: 4ELV7Z65AP)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73172-003-01	312 g in 1 JAR; 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(73172-003)