Your browser does not support JavaScript! BABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]
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BABYGANICS ECZEMA (oatmeal) lotion
[KAS Direct LLC dba BabyGanics]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

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 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: 4/2014
 
KAS Direct LLC dba BabyGanics

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