NDC 10356-101 Aquaphor Healing

Petrolatum

NDC Product Code 10356-101

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

NDC Product Information

Aquaphor Healing with NDC 10356-101 is a 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. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1052954 and 725145.

Dosage Form: Ointment - 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.

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.

Aquaphor Healing 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)
  • CERESIN (UNII: Q1LS2UJO3A)
  • LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • LEVOMENOL (UNII: 24WE03BX2T)

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: Beiersdorf Inc
Labeler Code: 10356
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: 01-01-1991 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: 12-31-2021 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.

Aquaphor Healing 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

Petrolatum 41%

Otc - Purpose

Skin Protectant OintmentTreatment 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.