NDC 57337-070 Baby Xtracare Oatmeal

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  3. NDC: 57337-070 Baby Xtracare Oatmeal

NDC Product Code 57337-070

NDC CODE: 57337-070

Proprietary Name: Baby Xtracare Oatmeal What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name: What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

NDC 57337-070-01

Package Description: 227 g in 1 BOTTLE

NDC 57337-070-02

Package Description: 354 g in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Baby Xtracare Oatmeal with NDC 57337-070 is a product labeled by Rejoice International. The generic name of Baby Xtracare Oatmeal is . The product's dosage form is and is administered via form.

Labeler Name: Rejoice International

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.
  • WATER (UNII: 059QF0KO0R)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • AVENA SATIVA WHOLE (UNII: 5P8D0Z74RG)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • LAURETH-7 (UNII: Z95S6G8201)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Rejoice International
Labeler Code: 57337
Start Marketing Date: 02-16-2015 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Baby Xtracare Oatmeal Product Label Images

Baby Xtracare Oatmeal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active Ingredient                                      PurposeDimethicone 1.2% ............................ Skin Protectant

Otc - Purpose

UseHelp prevent and temporarily protects chafed, chapped, or cracked skin.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center immediately.

Indications & Usage

Baby XtraCare®Oatmeal Daily Moisturizing LotionLightly ScentedDimethicon Skin Protectant with Natural Oat ExtractHelps Soothe & Soften Baby's Skin12 FL OZ (354 mL)

Dosage & Administration

DirectionsApply liberally as often as needed.

Warnings

WarningsFor extenal use only.When using this product avoid contact with eyes. In case of eye contact, flush with water.Stop use and ask a doctor if condition worsens. Symptoms last more than 7days or clear up and occur again within a few days.

Inactive Ingredient

Inactive Ingredientswater, petrolatum, mineral oil, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa (oatmeal) kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, aloe barbadensis leaf juice, methylparaben, propylparaben.

Other Safety Information

Other Information  Store at room temperature.Questions/Comments? 1-855-345-5575DISTRIBUTED BYREJOICE INTERNATIONAL INCNORTHVILLE, MI 48168 U.S.A.MADE IN CHINA

* Please review the disclaimer below.