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BabySpa Shea Butter Diaper

Dosage form: cream
Ingredients: Zinc Oxide 120mg in 1mL
Labeler: EXPRO3 LLC
NDC Code: 42957-001

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

Uses:

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

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)

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

Warnings:
For external use only

Stop use and ask a doctor if:

    * condition worsens
    * symptoms last more than 7 days

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.

BABYSPA  SHEA BUTTER DIAPER
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42957-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (Zinc Oxide) Zinc Oxide120 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SHEA BUTTER 
ALOE VERA FLOWER 
COCOA BUTTER 
YELLOW WAX 
STARCH, POTATO 
CETOSTEARYL ALCOHOL 
GRAPE SEED OIL 
KAOLIN 
SESAME OIL 
TITANIUM DIOXIDE 
PHENOXYETHANOL 
GLYCYRRHIZA GLABRA 
CALENDULA OFFICINALIS SEED OIL 
WATER 
PROPYL GALLATE 
LAURYL GLUCOSIDE 
EPIGALLOCATECHIN GALLATE 
GLYCERYL CAPRYLATE 
OLIVE OIL 
GLYCERIN 
CHAMAEMELUM NOBILE FLOWER 
BENZOIC ACID 
DEHYDROACETIC ACID 
BORAGE OIL 
OENOTHERA BIENNIS 
LAVANDULA ANGUSTIFOLIA FLOWER 
Packaging
#Item CodePackage Description
1NDC:42957-001-01100 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/18/2012
Labeler - EXPRO3 LLC (014904067)
Registrant - E.L. Erman Cosmetic Manufacturing Ltd (531894152)
Establishment
NameAddressID/FEIOperations
E.L. Erman Cosmetic Manufacturing Ltd531894152manufacture(42957-001)

Revised: 07/2012
Document Id: a383bfe6-3a12-4fe6-aa0a-34c9c2cde13e
Set id: 15c9f3c4-833a-4211-a0d0-31e754e7fb9f
Version: 1
Effective Time: 20120718
 
EXPRO3 LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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