NDC 53329-772 Aloe Vesta

Petrolatum

NDC Product Code 53329-772

NDC 53329-772-14

Package Description: 60 g in 1 BOTTLE, SPRAY

NDC Product Information

Aloe Vesta with NDC 53329-772 is a a human over the counter drug product labeled by Medline Industries, Lp. The generic name of Aloe Vesta is petrolatum. The product's dosage form is spray and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 672574 and 866791.

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 Vesta 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.

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

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: Medline Industries, Lp
Labeler Code: 53329
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: 09-01-2021 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 Vesta Product Label Images

Aloe Vesta 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

Active Ingredient

White petrolatum 36% w/w

Uses

  • Temporarily protects minor cuts, scrapes, and burnstemporarily protects and helps relieve chapped or cracked skinhelps treat and prevent diaper rashprotects minor skin irritation associated with diaper rash and helps seal out wetness

Warnings

For external use only. Flammable; keep away from heat or flame

Do Not Use On

  • Deep or puncture woundsanimal bitesserious burns

When Using This Product

  • Avoid spraying in eyesdo not intentionally inhaledo not puncture or incinerate; contents under pressure

Stop Using And See A Doctor If

  • Condition worsenssymptoms last more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children.

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

Directions

  • Do not oversprayshake before usehold can 4-6 inches from skin and sprayFor skin protectionapply as neededFor Diaper rashchange wet and soiled diapers promptly, cleanse the diaper area and allow to dryapply product liberally as often as necessary 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)for infants/neonates, please use under medical supervision

Inactive Ingredients

Aloe barbadensis leaf extract, bis-diglyceryl polyacyladipate-2, hexamethyldisiloxane, mineral oil

Manufacturing Information

Manufactured for Medline Industries, LPThree Lakes Drive, Northfield, IL 60093 USAMade in Sweden of foreign and domestic materialswww.medline.com1-800-MEDLINEREF: 413401V1RE21AUE

Purpose

Skin protectant

* Please review the disclaimer below.