BABYSPA CALMING RELIEF ECZEMA- colloidal oatmeal cream

BabySpa Calming Relief Eczema by

Drug Labeling and Warnings

BabySpa Calming Relief Eczema by is a Otc medication manufactured, distributed, or labeled by Expro3, LLC, EL Erman Manufacturing, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient Purpose

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

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children

INDICATIONS & USAGE

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

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

DOSAGE & ADMINISTRATION

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 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 cream

Product 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)