BABY ECZEMA MOISTURIZING- colloidal oatmeal cream 
Harmon Stores Inc.

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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buybuy Baby™ Eczema Moisturizing Cream

Active ingredient

Colloidal Oatmeal 1%

Purpose

Skin Protectant

Uses

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

•
Eczema
•
Rashes

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

Inactive ingredients

water, glycerin, distearyldimonium chloride, isopropyl palmitate, cetearyl alcohol, petrolatum, avena sativa (oat) kernel flour, dimethicone, steareth-21, panthenol (pro-vitamin B5), benzalkonium chloride, sodium chloride, ceramide 3, ceramide 6-II, ceramide 1, phytosphingosine, cholesterol, sodium lauroyl lactylate, carbomer, xanthan gum, sativa (oat) kernel oil, avena sativa (oat) kernel extract, triethanolamine.

Package/Label Principal Display Panel

buybuy
BABY™
eczema
MOISTURIZING
CREAM

colloidal oatmeal
skin protectant

Helps relieve dry, itchy
and irritated skin

Helps sooth eczema
related skin conditions

Steroid-free

Fragrance-free

DERMATOLOGIST
TESTED

NET WT 5 OZ (140 g)

baby eczema
moisturizing cream

Enriched with soothing oatmeal, this innovative cream offers relief to help care
for dry, itchy skin, while intensely moisturizing it. It helps to fortify your baby’s
skin's natural barrier functions while helping to prevent the recurrence of dry
skin. Our formula is enriched with ceramides, essential lipids naturally found in
the skin, to enhance and restore the baby’s skin's natural protective function.

MADE EXPRESSLY FOR
buybuy BABY™
650 Liberty Avenue,
Union, NJ 07083
© BUY BUY BABY INC.
WWW.BUYBUYBABY.COM
MADE IN ISRAEL

Carton Label

Container Label

BABY ECZEMA MOISTURIZING 
colloidal oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-429
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PETROLATUM (UNII: 4T6H12BN9U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
STEARETH-21 (UNII: 53J3F32P58)  
PANTHENOL (UNII: WV9CM0O67Z)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CERAMIDE 3 (UNII: 4370DF050B)  
CERAMIDE 6 II (UNII: F1X8L2B00J)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
XANTHAN GUM (UNII: TTV12P4NEE)  
OAT KERNEL OIL (UNII: 3UVP41R77R)  
OAT (UNII: Z6J799EAJK)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63940-429-12140 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/01/2014
Labeler - Harmon Stores Inc. (804085293)

Revised: 9/2014
Document Id: 970acac2-e16d-4d78-9570-37064147b250
Set id: 970acac2-e16d-4d78-9570-37064147b250
Version: 1
Effective Time: 20140912
 
Harmon Stores Inc.