NDC 68605-2007 Grandma Els

Diaper Rash Ointment

NDC Product Code 68605-2007

NDC 68605-2007-3

Package Description: 56.7 g in 1 TUBE

NDC 68605-2007-4

Package Description: 106.3 g in 1 JAR

NDC Product Information

Grandma Els with NDC 68605-2007 is a a human over the counter drug product labeled by Abbe Laboratories, Inc.. The generic name of Grandma Els is diaper rash ointment. The product's dosage form is ointment and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 1649558.

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.

Grandma Els 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.

  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CETYL ESTERS WAX (UNII: D072FFP9GU)
  • ETHYL METHYLPHENYLGLYCIDATE (UNII: UD51D5KR4A)
  • BENZYL CINNAMATE (UNII: V67O3RO97U)

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: Abbe Laboratories, Inc.
Labeler Code: 68605
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: 02-01-2015 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".

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Grandma Els Product Label Images

Grandma Els 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 IngredientsAmber Petroluatum 75.95%...........Lanolin 15.50%..............................

Otc - Purpose

Purpose.......Protectant, Emollient.......Protectant, Emollient

Indications & Usage

Uses: Helps treat and prevent diaper rash • Protects and heals chafed and irritated skin • Provides barrier to seal out wetness

Warnings

Warnings:For external use only

Otc - When Using

When using this product • do not get into eyes

Otc - Stop Use

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

Otc - Do Not Use

Do not use on • deep or puncture wounds • animal bites • serious burns

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

Dosage & Administration

Directions: Change wet and soiled diapers promptly. Cleanse diaper area and allow to dry. Apply a thin film of ointment to entire diaper area with every diaper change.

Other Safety Information

Other Information: Store at 20° to 25°C (68° to 77°F)

Inactive Ingredient

Other Ingredients:Tocopherol Acetate (Vitamin E), Cetyl Esters, Ethyl Methylphenylglycidate, Benzly Cinnamate (extracts of balsam of peru)

Otc - Questions

For Questions call (800) 457-0990 Mon-Fri

Other

Mfd. by ABBE Laboratories, Inc. Farmingdale, NYwww.GrandmaEls.com

———Package Label.Principal Disply Panel———

  • Warnings continued: Do not use on:  • deep or puncturewounds • animals bites  • serious burnsKeep out of reach of children.  If swallowed, getmedical help or contact a Poison Control CenterDirections: Change wet and soiled diapers promptly.Cleans diaper area and allow to dry.  Apply a thin film ofointment to entire diaper area with every diaper change.Other Information: Store at 20° to 25°C (68° to 77°F)Other Ingredients: Tocopherol Acetate (Vitamin E), Cetyl Esters,Ethyl Methylphenylglycidate, Benzyl Cinnamate(extracts of balsam of peru)For Questions call (800) 457-0990 Mon-FriMfd. by ABBE Laboratories, Inc. Farmingdale, NYwwwGrandmaEls.comCreates aBreathable BarrierUse with EveryDiaper ChangeSoothes, Calms+ HealsNET WT 3.75 OZ.GRANDMA EL'SDiaper Rash OintmentMade in the USAPediatrician RecommendedDOES NOT CONTAINPARABENS,PHTHALATES OR SLSDRUG FACTS:Active Ingredients                        PurposeAmber Petrolatum 75.95%..........Protectant, EmollientLanolin USP 15.50%...................Protectant, EmollientUses: Helps treat and prevent diaper rashProtects and heals chafed and irritated skinProvides barrier to seal out wetnessWarnings:For external use onlyWhen using this product  • do not get into eyesStop use and ask a doctor if  • condition worsens • symptoms last more than 7 days or clear up andoccur again within a few days2001-163 52248 00001 5

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