VITABATH BABY ECZEMA CARE INTENSIVE BALM- colloidal oatmeal 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 Eczema Care Intensive Balm

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

Jar Label

VITABATH BABY ECZEMA CARE INTENSIVE BALM 
colloidal oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73172-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73172-003-01312 g in 1 JAR; 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(73172-003)

Revised: 6/2019
Document Id: 8b363dda-a524-f077-e053-2995a90af37a
Set id: 8b35f8e3-a018-c5e9-e053-2a95a90aa03f
Version: 1
Effective Time: 20190613
 
Vitabath Inc.