BABYSPA SHEA BUTTER DIAPER- zinc oxide cream

BabySpa by

Drug Labeling and Warnings

BabySpa by is a Otc medication manufactured, distributed, or labeled by EXPRO3 LLC, E.L. Erman Cosmetic Manufacturing Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts
Active Ingredients            Purpose
Zinc Oxide 12%......................Skin Protectant

PURPOSE

Uses:

    * Helps treat and prevent diaper rash and other minor skin irritations
    * Seals out wetness

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Directions:
Apply cream liberally, as often as necessary, with each diaper change for continuous protection

WARNINGS

Warnings:
For external use only

DOSAGE & ADMINISTRATION

Stop use and ask a doctor if:

    * condition worsens
    * symptoms last more than 7 days

INACTIVE INGREDIENT

shea butter (butyrospermum parkii), aloe barbadensis gel, cocoa (theobroma cacao) butter, beeswax, potato (solanium tuberosum) starch, cetearyl alcohol, grape (vitis vinifera) seed oil, kaolin, sesame (sesamum indicum) oil, titanium dioxide, phenoxyethanol, licorice (glycyrrhiza glabra) root extract, calendula officinalis seed oil, Unisooth EG-28 (water  propyl gallate  gallyl glucoside  epigallocatechin gallatyl glucoside), glyceryl caprylate, olive (olea europaea) oil*, glycerin, chamomile (anthemis nobilis ) extract, benzoic acid, dehydroacetic acid, borage (borago officinalis) seed oil, evening primrose (oenothera biennis) oil, fragrance, lavender (lavandula angustifolia) extract.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BABYSPA  SHEA BUTTER DIAPER
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42957-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SHEA BUTTER (UNII: K49155WL9Y)
ALOE VERA FLOWER (UNII: 575DY8C1ER)
COCOA BUTTER (UNII: 512OYT1CRR)
YELLOW WAX (UNII: 2ZA36H0S2V)
STARCH, POTATO (UNII: 8I089SAH3T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GRAPE SEED OIL (UNII: 930MLC8XGG)
KAOLIN (UNII: 24H4NWX5CO)
SESAME OIL (UNII: QX10HYY4QV)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)
WATER (UNII: 059QF0KO0R)
PROPYL GALLATE (UNII: 8D4SNN7V92)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
OLIVE OIL (UNII: 6UYK2W1W1E)
GLYCERIN (UNII: PDC6A3C0OX)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
BORAGE OIL (UNII: F8XAG1755S)
OENOTHERA BIENNIS (UNII: 76UI55V071)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42957-001-01	100 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/18/2012

Labeler - EXPRO3 LLC (014904067)

Registrant - E.L. Erman Cosmetic Manufacturing Ltd (531894152)

Establishment
Name	Address	ID/FEI	Business Operations
E.L. Erman Cosmetic Manufacturing Ltd		531894152	manufacture(42957-001)