ECZEMA CARE SKIN PROTECTANT- 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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eczema care skin protectant cream

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) butter1, cetearyl alcohol, cetyl alcohol, isopropyl palmitate, glycerin1, glyceryl stearate, theobroma cacao (cocoa) seed butter1, hydrolyzed oats, solanum lycopersicum (tomato) seed oil, helianthus annuus (sunflower) seed oil1, vaccinium macrocarpon (cranberry) seed oil, nigella sativa (black cumin) seed oil1, rubus idaeus (red raspberry) seed oil, cetearyl glucoside, tocopherol, glyceryl dilaurate, caprylyl glycol, xanthan gum, sodium hydroxide, sodium phytate, triethyl citrate, ethylhexylglycerin, benzoic acid.

1
Certified Organic Ingredient
Unless otherwise specified, product not labeled as organic

dist. by KAS direct, LLC
Westbury, NY 11590

PRINCIPAL DISPLAY PANEL - 226 g Tube Label

ACCEPTED
NATIONALECZEMA.ORG
NATIONAL
ECZEMA
ASSOCIATION

babyganics

eczema care skin
protectant cream

fragrance free

relieves dry, itchy,
irritated skin
non-allergenic ∙
pediatrician &
dermatologist tested

formulated with:
colloidal oatmeal*

formulated without:
cortisone, steroids,
parabens, phthalates
or fragrances

Discover which of
our ingredients are
Certified Organic
on back panel.

Net wt 8 OZ (226 g)

PRINCIPAL DISPLAY PANEL - 226 g Tube Label
ECZEMA CARE SKIN PROTECTANT 
oatmeal lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-1305
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
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)  
TOMATO (UNII: Z4KHF2C175)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
SOYBEAN OIL (UNII: 241ATL177A)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59062-1305-8226 g in 1 TUBE; Type 0: Not a Combination Product04/08/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34704/08/2019
Labeler - KAS Direct LLC dba BabyGanics (002764605)

Revised: 7/2020
Document Id: c98d9c03-2e70-4d88-94c0-f5152e787ed1
Set id: 25884297-6933-4812-9356-b49a561a681e
Version: 1
Effective Time: 20200717
 
KAS Direct LLC dba BabyGanics