NDC 11914-036 Aloe Barrier
Petrolatum Spray Topical

Product Information

Product Code11914-036
Proprietary Name 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.
Aloe Barrier
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.
Petrolatum
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.
Human Otc Drug
Dosage FormSpray - A liquid minutely divided as by a jet of air or steam.
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.
Aurena Laboratories Ab
Labeler Code11914
FDA Application Number 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.
part347
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
12-15-2020
End Marketing Date What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
09-30-2022
Exclude Flag 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".
N
NDC Code Structure

Usage Information


Product Packages

NDC 11914-036-60

Package Description: 60 g in 1 BOTTLE, SPRAY

Product Details

Aloe Barrier is a human over the counter drug product labeled by Aurena Laboratories Ab. The generic name of Aloe Barrier is petrolatum. The product's dosage form is spray and is administered via topical form.


What are Aloe Barrier Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct code indicates a single concept unique identifier (RXCUI) is associated with this product:


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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
  • HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)


* Please review the disclaimer below.

Aloe Barrier Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Drug Facts


Active Ingredient



Petrolatum 36%


Purpose



Skin Protectant


Uses



  • Temporarily protects minor
    -cuts
    -scrapes
    -burns.
  • Temporarily protects and helps relieve chapped or cracked skin and lips. 
  • Helps treat and prevent diaper rash.
  • Protects minor skin irritation associated with diaper rash and helps seal out wetness.

Warnings



For external use only.


Do Not Use On



  • deep or puncture wounds
  • animal bites
  • serious burns.

When Using This Product



  • avoid spraying in eyes
  • do not intentially inhale.

Stop Use And Ask A Doctor If



condition last more than 7 days.


Keep Out Of Reach Of Children.



If swallowed, get medical help or consult a Poison Control Center right away.


Directions



​Do not overspray. Shake before use. Hold can 4-6 inches from skin and spray.

​For skin protection:

  • ​Apply a thin continuous coating as needed.
  • ​For diaper rash:

    • Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.
    • Apply as needed, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.

Other Information​



Store at 15° C - 30° C (59° F - 86°F)


Inactive Ingredients



Aloe Barbedensis Leaf Extract, Bis-Diglyceryl Polyacyladipate-2, Hexamethyldisiloxane, MIneral Oil


Package Label Display



NDC 11914-036-60

ALOE BARRIER SPRAY

3 PROTECT

CLEAR BARRIER SPRAY

  • Skin Protectant
  • CHG Comopatible
  • Soothes Irritated Skin
  • For Weepy, Denuded Skin
  • Fragrance & Dye Free
  • Easy to Remove
  • For All Ages
  • with a Natural Botanical

    • Shake Before Use
    • Apply from Any Angle
    • Net Wt. 2.1 oz. (60g)

      Made in Sweden

      CONTAINS NO CFCS WHICH DEPLETE THE OZONE LAYER


* Please review the disclaimer below.