Label: BABYSPA CALMING RELIEF ECZEMA- colloidal oatmeal cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 42957-002-01, 42957-002-02, 42957-002-03 - Packager: Expro3, LLC
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated March 7, 2013
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
-
INACTIVE INGREDIENT
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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BABYSPA CALMING RELIEF ECZEMA
colloidal oatmeal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42957-002 Route of Administration TOPICAL 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)