NDC 10356-101 Aquaphor Healing
Petrolatum Ointment Topical

Product Information

Product Code10356-101
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.
Aquaphor Healing
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 FormOintment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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.
Beiersdorf Inc
Labeler Code10356
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.
01-01-1991
Listing Expiration Date 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.
12-31-2022
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 10356-101-02

Package Description: 7 g in 1 TUBE

NDC 10356-101-06

Package Description: 50 g in 1 TUBE

NDC 10356-101-08

Package Description: 85 g in 1 TUBE

NDC 10356-101-10

Package Description: 99 g in 1 JAR

NDC 10356-101-23

Package Description: 10 g in 1 TUBE

NDC 10356-101-29

Package Description: 4 g in 1 TUBE

NDC 10356-101-30

Package Description: .9 g in 1 PACKET

NDC 10356-101-35

Package Description: 141 g in 1 TUBE

NDC 10356-101-37

Package Description: 396 g in 1 JAR

NDC 10356-101-38

Package Description: 198 g in 1 TUBE

NDC 10356-101-39

Package Description: 7 g in 1 JAR

NDC 10356-101-40

Package Description: 2 TUBE in 1 CARTON > 10 g in 1 TUBE (10356-101-23)

NDC 10356-101-42

Package Description: 1.7 g in 1 PACKET

NDC 10356-101-43

Package Description: 250 PACKET in 1 CARTON > 1.7 g in 1 PACKET (10356-101-42)

NDC 10356-101-44

Package Description: 144 PACKET in 1 CARTON > .9 g in 1 PACKET (10356-101-30)

NDC 10356-101-49

Package Description: 297 g in 1 JAR

NDC 10356-101-50

Package Description: 43 g in 1 TUBE

Product Details

Aquaphor Healing is a human over the counter drug product labeled by Beiersdorf Inc. The generic name of Aquaphor Healing is petrolatum. The product's dosage form is ointment and is administered via topical form.


What are Aquaphor Healing 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 indicates multiple concept unique identifiers (RXCUIs) are 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.

  • MINERAL OIL (UNII: T5L8T28FGP)
  • CERESIN (UNII: Q1LS2UJO3A)
  • LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • LEVOMENOL (UNII: 24WE03BX2T)


* Please review the disclaimer below.

Aquaphor Healing 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



Otc - Active Ingredient



Petrolatum 41%


Otc - Purpose



Skin Protectant Ointment

Treatment or Prevention of Diaper Rash



Indications & Usage



Uses

• temporarily protects minor: • cuts • scrapes • burns
• temporarily protects and helps relieve chapped or cracked skin and lips
• helps protect from the drying effects of wind and cold weather

• helps treat and prevent diaper rash
• protects chafed skin associated with diaper rash and helps protect from wetness


Warnings



When using this product • do not get into eyes


Otc - Do Not Use



Do not use on

• deep or puncture wounds • animal bites
• serious burns


Otc - Stop Use



Stop use and ask a doctor if • condition worsens
• symptoms last more than 7 days or clear up and occur
again within a few days


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.


Inactive Ingredient



Mineral Oil, Ceresin, Lanolin Alcohol,
Panthenol, Glycerin, Bisabolol


Otc - Questions



Questions or comments?
1-800-227-4703


Dosage & Administration



Directions

• apply as needed

• for diaper rash, change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry. Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.


* Please review the disclaimer below.