NDC 81877-512 Dicloprep-100

Diclofenac Sodium, Isopropyl Alcohol

NDC Product Code 81877-512

NDC CODE: 81877-512

Proprietary Name: Dicloprep-100 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.

Non-Proprietary Name: Diclofenac Sodium, Isopropyl Alcohol 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.

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)

NDC Code Structure

  • 81877 - Forreal Pharmaceuticals Llc

NDC 81877-512-10

Package Description: 1 KIT in 1 PACKAGE * 1 TUBE in 1 CARTON (70512-106-10) > 100 g in 1 TUBE

NDC Product Information

Dicloprep-100 with NDC 81877-512 is a a human over the counter drug product labeled by Forreal Pharmaceuticals Llc. The generic name of Dicloprep-100 is diclofenac sodium, isopropyl alcohol. The product's dosage form is kit and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 855633.

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • AMMONIA (UNII: 5138Q19F1X)
  • CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
  • COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Forreal Pharmaceuticals Llc
Labeler Code: 81877
Marketing Category: UNAPPROVED DRUG OTHER - 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: 12-20-2021 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.

Information for Patients

Diclofenac Topical (actinic keratosis)

Diclofenac Topical (actinic keratosis) is pronounced as (dye kloe' fen ak)

Why is diclofenac topical (actinic keratosis) medication prescribed?
Diclofenac topical gel (Solaraze) is used to treat actinic keratosis (flat, scaly growths on the skin caused by too much sun exposure). Diclofenac is in a class of medica...
[Read More]

* Please review the disclaimer below.

Dicloprep-100 Product Label Images

Dicloprep-100 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

(NSAID) - arthritis pain relieverActive ingredientDiclofenac sodium (NSAID*) 1%*nonsterodial anti-inflammatory drug

Otc - Purpose

PurposeArthritis pain reliever

Indications & Usage

  • Usesfor the temporary relief of arthritis pain
  • ONLY in the following areas:
  • – hand, wrist, elbow (upper body areas)– foot, ankle, knee (lower body areas)This product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If not pain relief in 7 days, stop use

Warnings

WarningsFor external use onlyAllergy alert: Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:• hives • asthma (wheezing) • skin reddening • blisters • facial swelling • shock • rashIf an allergic reaction occurs, stop use and seek medical help right away.Liver warning: This product contains diclofenac. Liver damage may occur if you apply
• more or for a longer time than directed• when using other drugs containing diclofenacStomach bleeding warning: This product contain an NSAID, which may cause severe stomach bleeding. The chance is small but high but higher if you
• are age 60 or older• have had stomach ulcers or bleeding problems• take a blood thinning (anticoagulant) or steroid drug• take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)• have 3 or more alcoholic drinks every day while using this product• apply more or for longer than directedHeart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attach, heart failure, and stroke. These can be fatal. The rish is higher if you use more than directed or for longer than directed.

  • For External Use OnlyAvoid contact with the eyes. If contact occurs, flush eyes with water

Otc - Do Not Use

  • Do not useif you have ever had an allergic reaction to any other pain reliever or to a fever reducerfor strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.right before or after heart surgeryon more than 2 body areas at the same timein the eyes, nose or mouth

Otc - Ask Doctor

  • Ask a doctor before use ifyou have problems or serious side effects from taking pain relievers or fever reducersstomach bleeding warning applies to you or you have a history of stomach prohlems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a strokeyou are taking a diureticyou are under the age of 18 years. It is not known if this drug works or is safe in children under age 18 years.

Otc - Ask Doctor/Pharmacist

  • Ask a doctor or pharmacist before use if you areunder a doctor's care for any serious conditiontaking any other drug

Otc - When Using

  • When using this productavoid contact with eyes, nose, or mouthif eye contact occurs, rinse thoroughly with water

Otc - Stop Use

  • Stop use and ask a doctor ifpain gets worse or last more than 21 daysredness or swelling is present in the painful areafever occursskin irritation occursany new symptoms appear. These could be signs of a serious condition.you experience any of the following signs of stomach bleedingfeel fainthave bloody or black stoolsvomit bloodhave stomach pain that does not get betteryou have symptoms of heat problems or strokechest paintrouble breathingleg swellingweakness in one part or side of bodyslurred speech

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feedingask a health care professional before use. It is especially important not to use this product during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Otc - Keep Out Of Reach Of Children

Keep our of reach of childrenIf swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • DirectionsUse up to 21 days unless directed by your doctorNot for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.Daily For arthritis pain:Use 4 times per day every day
  • Do not use on more than 2 body areas at the same time
  • Per Dose (Use ENCLOSED DOSING CARD to measure a dose) –For each upper body area (hand, wrist, or elbow) - Squeeze out 2.25 inches (2 grams) –For each lower body area (foot, ankle, or knee) - Squeeze out 4.5 inches (4 grams)Read the enclosed User Guide for complete instructions:use only as directed
  • Do not use more than directed or for longer than directed
  • Apply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes
  • Do not apply in the same area as any other product
  • Do not apply with external heat such as heating pad
  • Do not apply a bandage over the treated area
  • Store ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1% Arthritis Pain. The dosing card is re-usable.

Other Safety Information

  • Other InformationStore at 20-25°C (68°F - 77°F). Keep from freezing.read all product information before using. Keep the dossing card, the carton and accomanying User guide for important information.

Inactive Ingredient

Inactive ingredientsCarbomer homopolymer Type C, cocoyl caprylocaprate, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution.

Otc - Questions

Questions and comments 1-866-747-7365

Active Ingredient

Isopropyl Alcohol, 70% v/v

Purpose

Antiseptic

Uses

  • Antiseptic cleanserKills harmful bacteria and germsFirst aid help prevent infection

Do Not Use

  • With electrocautery proceduresIn the eyes

Stop Use And Ask A Doctor If

  • Irritation and redness developsIf condition persists for more than 72 hours, consult a physician

Discontinue Use And Consult A Healthcare Practitioner If

  • Irritation develops

Keep Out Of Reach Of Children

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

Directions

  • Use as part of your daily cleansing routineMay be covered with a sterile bandage

Other Information

  • Store at room temperature 15°-30°C (59°-86°F)Avoid excessive heat

Inactive Ingredients

Water

How Supplied/Storage And Handling

Diclofenac sodium topical gel, 1% is available in tubes containing 100 g of the topical gel in each tube. Each tube contains diclofenac sodium in a gel base (10 mg of diclofenac sodium per gram of gel or 1%).100 g tubeNDC 70512-0106-10

Storage And Handling

StorageStore at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep from freezing. Store the dosing card with your diclofenac sodium topical gel.

Dicloprep-100

NDC: 81877-512-10DICLOPREP-100Topical KitDiclofenac Sodium Topical Gel, 1 %(100 g)Sterile Alcohol Prep Pads(Isopropyl alcohol, 100 count)See enclosed insert(s) for full prescribing informationUsual Dosage: See package insert for dosage and full prescribing information.Storage: Store at 20° to 25°C (68°-77°F) [see USP Controlled Room Temperature].Keep this and all medication out of reach of children.Packaged For: Forreal Pharmaceuticals, LLCRoyal Oak, MI 48067Questions or Comments please call 877-367-3250Forreal Pharmaceuticals LLC

* Please review the disclaimer below.