Babyganics Eczema (Oatmeal) Lotion [Kas Direct Llc Dba Babyganics] -

BABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]
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NDC	59062-1304-1
Set ID	cd062efe-f695-46bd-a89c-f2f6acf6e24a
Category	HUMAN OTC DRUG LABEL
Packager	KAS Direct LLC dba BabyGanics
Generic Name
Product Class
Product Number
Application Number	PART347

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SPL UNCLASSIFIED SECTION

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
SPL UNCLASSIFIED SECTION

Dist. by:
KAS Direct, LLC.
Hicksville, NY 11801
PRINCIPAL DISPLAY PANEL - 226 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

8 OZ (226g)

INGREDIENTS AND APPEARANCE

BABYGANICS ECZEMA
oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59062-1304
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59062-1304-1	226 g in 1 TUBE; Type 0: Not a Combination Product	06/21/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	06/21/2013

Labeler - KAS Direct LLC dba BabyGanics (002764605)

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Medic

BABYGANICS ECZEMA (OATMEAL) LOTION [KAS DIRECT LLC DBA BABYGANICS]

Stop use and ask a doctor if

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