Your browser does not support JavaScript! BABYSPA CALMING RELIEF ECZEMA (COLLOIDAL OATMEAL) CREAM [EXPRO3, LLC]
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BABYSPA CALMING RELIEF ECZEMA (colloidal oatmeal) cream
[Expro3, LLC]


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

Active Ingredient Purpose

Colloidal Oatmeal 0.1%............Skin Protectant

Intensively Hydrates & Naturally Helps to Relieve Dry, Itchy, Irritated Skin due to Eczema & Rashes

Keep out of the reach of children

Uses:

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

  • eczema
  • rashes

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

If swallowed, get medical help or contact a Poison Control Center right away. (U.S. - 1-800-222-1222)

Directions:

  • Apply liberally to dry, itchy patches and irritated skin, as often as necessary.
  • Suitable for daily use.
  • Delicate enough to use on newborn skin.

Other Information:

For use on mild to moderate excema or as directed by a physician. Store at room temperature.

Inactive Ingredients:

water (aqua), vegetable glycerin, caprylic/capric/triglyceride, simmondsia chinensis (jojoba) seed oil*, butyrospermum parkii (shea butter), cetyl alcohol, aloe vera barbadensis leaf juice*, symphytum officinale leaf extract, phenoxyethanol, xanthan gum, caprylyl glycol, calendula officinalis flower oil, avena sativa (oat) kernel extract, bisabolol, anthemis nobilis (chamomile) flower extract*.

*certified organic

box label

BABYSPA CALMING RELIEF ECZEMA 
colloidal oatmeal cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:42957-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (OATMEAL) OATMEAL1.25 g  in 125 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
MEDIUM-CHAIN TRIGLYCERIDES 
JOJOBA OIL 
SHEA BUTTER 
CETYL ALCOHOL 
ALOE VERA LEAF 
COMFREY LEAF 
PHENOXYETHANOL 
XANTHAN GUM 
CAPRYLYL GLYCOL 
CALENDULA OFFICINALIS FLOWER 
LEVOMENOL 
CHAMAEMELUM NOBILE FLOWER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42957-002-021 in 1 BOX
1NDC:42957-002-01125 g in 1 TUBE
2NDC:42957-002-034 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/25/2013
Labeler - Expro3, LLC (014904067)
Establishment
NameAddressID/FEIBusiness Operations
EL Erman Manufacturing, Ltd.531894152manufacture(42957-002)

Revised: 3/2013
 
Expro3, LLC

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