BABYGANICS ECZEMA- oatmeal lotion 
KAS Direct LLC dba BabyGanics

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.

----------

babyganics® Eczema Lotion

Drug Facts

Active ingredient

Colloidal oatmeal 1%

Purpose

Skin protectant

Uses

temporarily protects and helps relieve minor skin irritation and itching due to:

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

Other information

Store at room temperature 59-77°F (15-25°C)

Inactive ingredients

water, butyrospermum parkii (shea) butter, cetearyl alcohol, cetyl alcohol, isopropyl palmitate, glycerin, glyceryl stearate, theobroma cacao (cocoa) seed butter, hydrolyzed oats, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil, rubus idaeus (red raspberry) seed oil, cetearyl glucoside, tocopherol, glyceryl dilaurate, caprylyl glycol, xanthan gum, sodium phytate, ethylhexylglycerin, citric acid, sodium hydroxymethylglycinate

Dist. by:
KAS Direct, LLC.
Hicksville, NY 11801

PRINCIPAL DISPLAY PANEL - 85 g Tube Label

extra
soothing

babyganics®

eczema care
skin protectant cream

with colloidal oatmeal ∙ relieves dry,
itchy, irritated skin ∙ non–allergenic
pediatrician & dermatologist tested

no: cortisone, steroids, parabens,
sulfates, phthalates or fragrances

+ NeoNourish* Natural Seed Oil Blend

3 OZ (85g)

Principal Display Panel - 85 g Tube Label
BABYGANICS ECZEMA 
oatmeal lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59062-1303
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
SHEA BUTTER (UNII: K49155WL9Y)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
COCOA BUTTER (UNII: 512OYT1CRR)  
OAT (UNII: Z6J799EAJK)  
NIGELLA SATIVA SEED OIL (UNII: CS4U38E731)  
CARROT SEED OIL (UNII: 595AO13F11)  
CHIA SEED OIL (UNII: MC2LH51BO7)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
TOCOPHEROL (UNII: R0ZB2556P8)  
GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PHYTATE SODIUM (UNII: 88496G1ERL)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59062-1303-1 85 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part347 06/21/2013
Labeler - KAS Direct LLC dba BabyGanics (002764605)

Revised: 4/2014
Document Id: 12de681d-9919-4bee-ad1d-acf4186f72bd
Set id: 8dc620b9-6d75-46a3-9a8d-d796d5027b0f
Version: 2
Effective Time: 20140408
 
KAS Direct LLC dba BabyGanics