NDC 57337-060 Xtracare Creamy Petroleum Jelly

Petrolatum

NDC Product Code 57337-060

NDC 57337-060-01

Package Description: 127 g in 1 PACKAGE

NDC Product Information

Xtracare Creamy Petroleum Jelly with NDC 57337-060 is a a human over the counter drug product labeled by Rejoice International. The generic name of Xtracare Creamy Petroleum Jelly is petrolatum. The product's dosage form is jelly and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1037285.

Dosage Form: Jelly - A class of gels, which are semisolid systems that consist of suspensions made up of either small inorganic particles or large organic molecules interpenetrated by a liquid--in which the structural coherent matrix contains a high portion of liquid, usually water.

Product Type: Human Otc Drug 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.

Xtracare Creamy Petroleum Jelly Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


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)
  • CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)
  • D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

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
FDA Application Number: part347 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-18-2014 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: 12-31-2022 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: N - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Xtracare Creamy Petroleum Jelly Product Label Images

Xtracare Creamy Petroleum Jelly 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:                                       PurposePetrolatum 30% ................................ Skin Protectant

Otc - Purpose

  • Usestemporarily protects minor: cuts, scrapes, burnstemporarily protects and helps relieve chapped or cracked skinhelps protect from the drying effects of wind and cold weather

Otc - 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.

Indications & Usage

XtraCare® Creamy Petroleum JellyCocoa Butter enrichedSkin ProtectorDry Skin ReliefRich Creamy Moisturiser*Compare to the active ingredient in Vaseline® Petroleum Jelly CreamNet Wt 4.5oz (127g)Xtracare®XtraCare Creamy Petroleum Jelly is specially formulated to moisturize, soften and soothe dry skin. Blended with Coco butter oil to product a rich creamy moisturizer. Use on hands, knees, feet and heels to smooth away dryness. Great for moisturizing face and neck.

Warnings

  • Warningsfor external use only.When using this product do not get into eyes.Stop use and ask a doctor ifcondition worsenssymptoms last more than 7 days or clear up and occur again within a few daysDo not use on deep puncture woundsanimal bitesserious burns

Dosage & Administration

Directions apply as needed.

Inactive Ingredient

Inactive Ingredients: water, carbomer, stearic acid, mineral oil, cetyl alcohol, glycerin, ceteareth-20, glyceryl monostearate, methylparaben, propylparaben, DMDM hydantoin, triethanolamine, disodium EDTA, theobroma cacao (cocoa) seed butter, fragrance, FD&C yellow no.5, FD&C red no.40, D&C red no.33.

Other Safety Information

Other informationstore at room temperature.Questions/Comments? 1-855-345-5575*this product is nor manufactured or distributed by UNILEVER, distributor of the registered trademark Vaseline®.DISTRIBUTED BYREJOICE INTERNATIONAL INCNORTHVILLE, MI 48168 USAMADE IN CHINA

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