Label: BABYSPA CALMING RELIEF ECZEMA- oatmeal cream
- NDC Code(s): 42957-002-01, 42957-002-02, 42957-002-03
- Packager: Expro3, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated March 7, 2013
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- ACTIVE INGREDIENT
Active Ingredient Purpose
Colloidal Oatmeal 0.1%............Skin ProtectantClose
Intensively Hydrates & Naturally Helps to Relieve Dry, Itchy, Irritated Skin due to Eczema & RashesClose
- KEEP OUT OF REACH OF CHILDREN
Keep out of the reach of childrenClose
- INDICATIONS & USAGE
Temporarily protects and helps relieve minor skin irritation and itching due to:
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)Close
- DOSAGE & ADMINISTRATION
- Apply liberally to dry, itchy patches and irritated skin, as often as necessary.
- Suitable for daily use.
- Delicate enough to use on newborn skin.
For use on mild to moderate excema or as directed by a physician. Store at room temperature.Close
- INACTIVE INGREDIENT
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*.
- INGREDIENTS AND APPEARANCE
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)