NDC 46122-676 Good Neighbor Pharmacy Skin Protectant

Zinc Oxide

NDC Product Code 46122-676

NDC 46122-676-46

Package Description: 1 TUBE in 1 CARTON > 57 g in 1 TUBE

NDC Product Information

Good Neighbor Pharmacy Skin Protectant with NDC 46122-676 is a a human over the counter drug product labeled by Amerisource Bergen. The generic name of Good Neighbor Pharmacy Skin Protectant is zinc oxide. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Amerisource Bergen

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.

Good Neighbor Pharmacy Skin Protectant 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.

  • ZINC OXIDE .2 g/g

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)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • PETROLATUM (UNII: 4T6H12BN9U)

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: Amerisource Bergen
Labeler Code: 46122
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: 05-17-2021 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.

Good Neighbor Pharmacy Skin Protectant Product Label Images

Good Neighbor Pharmacy Skin Protectant 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

Active ingredient PurposeZinc oxide 20%...............................................Skin protectant

Otc - Purpose

  • Useshelps treat and prevent diaper rashprotects chafed skin due to diaper rash and helps seal out wetnessprotects and dries the oozing and weeping of poison ivy, oak and sumachelps prevent and temporarily protect chafed, chapped, cracked, or windburned skin and lips

Warnings

Warnings For external use only

Otc - When Using

  • When using this productdo not get into eyes

Otc - Stop Use

  • Stop use and ask a doctor ifcondition worsenssymptoms 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 (1-800-222-1222) right away.

Indications & Usage

  • Directionsfor diaper rash:change wet and soiled diapers promptlycleanse the diaper area and allow to dryapply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolongedfor poison ivy, oak, sumac, chafed, chapped, cracked or windburned skin and lips:apply liberally as often as needed

Storage And Handling

  • Other informationstore at room temperature 20-25°C (68-77°F)may stain clothing

Inactive Ingredient

Inactive ingredients .alpha.-tocopherol acetate, aloe vera leaf, light mineral oil, praffin, petrolatum

Dosage & Administration

Distributed by:Amerisource Bergen1300 Morris DriveChesterbrook, PA 19087Made in China

* Please review the disclaimer below.