BABYSPA CALMING RELIEF ECZEMA- oatmeal cream 
Expro3, LLC

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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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:

For external use only

When using this product:

Stop use and ask a doctor if:

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

Directions:

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 Type HUMAN OTC DRUG Item Code (Source) NDC:42957-002
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 1.25 g  in 125 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
JOJOBA OIL (UNII: 724GKU717M)  
SHEA BUTTER (UNII: K49155WL9Y)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
COMFREY LEAF (UNII: DG4F8T839X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
LEVOMENOL (UNII: 24WE03BX2T)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42957-002-02 1 in 1 BOX
1 NDC:42957-002-01 125 g in 1 TUBE
2 NDC:42957-002-03 4 g in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 03/25/2013
Labeler - Expro3, LLC (014904067)
Establishment
Name Address ID/FEI Business Operations
EL Erman Manufacturing, Ltd. 531894152 manufacture(42957-002)

Revised: 3/2013
Document Id: 98405d64-9dc9-4dfd-9045-3bcdfacd360b
Set id: 4999358e-e799-4267-9a0f-336a948d9d87
Version: 1
Effective Time: 20130307
 
Expro3, LLC