BABYGANICS BYE, BYE DRY 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.

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BabyGanics® Bye, Bye Dry 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:

  • rashes
  • eczema

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

  • apply as needed
  • massage into baby's skin, especially after bathing - perfect for face and body
  • for use on mild to moderate eczema or as directed by a physician

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

PEDIATRICIAN & DERMATOLOGIST
TESTED

BabyGanics®

Cortisone & Steroid Free • Hypoallergenic
BYE BYE DRY

MOISTURIZING
Eczema Care
Skin Protectant Cream
with Colloidal Oatmeal

with Neo Nourish Complex™
Nurtures & Supports Baby 's Skin

100% Natural Seed Oil

Extra Soothing Relief for
Dry, Itchy, Irritated Skin

No Parabens, Sulfates,
Phthalates or Toxins

Specially Formulated with
Natural, Plant-Based Ingredients

3 OZ (85 g)

Principal Display Panel - 85 g Tube Label
BABYGANICS BYE, BYE DRY ECZEMA 
oatmeal lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:59062-1303
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (OATMEAL) OATMEAL10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SHEA BUTTER 
CETOSTEARYL ALCOHOL 
CETYL ALCOHOL 
ISOPROPYL PALMITATE 
GLYCERIN 
GLYCERYL MONOSTEARATE 
COCOA BUTTER 
OAT 
NIGELLA SATIVA SEED OIL 
CARROT SEED OIL 
CHIA SEED OIL 
RASPBERRY SEED OIL 
CRANBERRY SEED OIL 
CETEARYL GLUCOSIDE 
TOCOPHEROL 
GLYCERYL DILAURATE 
CAPRYLYL GLYCOL 
XANTHAN GUM 
PHYTATE SODIUM 
ETHYLHEXYLGLYCERIN 
CITRIC ACID MONOHYDRATE 
SODIUM HYDROXYMETHYLGLYCINATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59062-1303-185 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34706/21/2013
Labeler - KAS Direct LLC dba BabyGanics (002764605)

Revised: 7/2013
Document Id: 1b19e2fe-9900-4451-a885-b059b5d9b363
Set id: 8dc620b9-6d75-46a3-9a8d-d796d5027b0f
Version: 1
Effective Time: 20130718
 
KAS Direct LLC dba BabyGanics