NDC 11914-036 Aloe Barrier

Petrolatum

NDC Product Code 11914-036

NDC 11914-036-60

Package Description: 60 g in 1 BOTTLE, SPRAY

NDC Product Information

Aloe Barrier with NDC 11914-036 is a 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. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 672574.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Aloe Barrier 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.

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

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: Aurena Laboratories Ab
Labeler Code: 11914
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: 12-15-2020 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".

* Please review the disclaimer below.

Aloe Barrier Product Label Images

Aloe Barrier 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

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 woundsanimal bitesserious burns.

When Using This Product

  • Avoid spraying in eyesdo 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 11914-036-60ALOE BARRIER SPRAY3 PROTECTCLEAR BARRIER SPRAYSkin ProtectantCHG ComopatibleSoothes Irritated SkinFor Weepy, Denuded SkinFragrance & Dye FreeEasy to RemoveFor All Ageswith a Natural BotanicalShake Before UseApply from Any AngleNet Wt. 2.1 oz. (60g)Made in SwedenCONTAINS NO CFCS WHICH DEPLETE THE OZONE LAYER

* Please review the disclaimer below.