NDC 0067-8153 Voltaren Arthritis Pain

Diclofenac Sodium

NDC Product Code 0067-8153

NDC 0067-8153-01

Package Description: 1 KIT in 1 CARTON * 2 TUBE in 1 KIT > 150 g in 1 TUBE * 1 TUBE in 1 KIT > 50 g in 1 TUBE

NDC Product Information

Voltaren Arthritis Pain with NDC 0067-8153 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Voltaren Arthritis Pain is diclofenac sodium. The product's dosage form is kit and is administered via form.

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc

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.

  • AMMONIA (UNII: 5138Q19F1X)
  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • AMMONIA (UNII: 5138Q19F1X)
  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • AMMONIA (UNII: 5138Q19F1X)
  • CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
  • COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • 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: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0067
FDA Application Number: NDA022122 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: NDA - A product marketed under an approved New Drug Application. 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: 05-13-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Voltaren Arthritis Pain 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

Active Ingredient

Diclofenac sodium 1% (NSAID*)*nonsteroidal anti-inflammatory drug

Purpose

Arthritis pain reliever

Keep Out Of Reach Of Children.

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

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

Uses

  • •for the treatment of arthritis pain ONLY in the following areas:ohand, wrist, elbow (upper body areas)ofoot, ankle, knee (lower body areas) •this product may take up to 7 days to work for arthritis pain; it is not for immediate relief

Warnings

  • For 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 contains an NSAID, which may cause severe stomach •bleeding. The chance is small 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 nonprescription 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 attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do Not Use

  • •if you have ever had an allergic reaction to any other pain reliever/fever reducer •for strains, sprains, bruises or sports injuries •right before or after heart surgery •on more than 2 body areas at the same time •in the eyes, nose or mouth

Ask A Doctor Before Use If

  • •you have problems or serious side effects from taking pain relievers or fever reducers •stomach bleeding warning applies to you •you have a history of stomach problems, such as heartburn •you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke •you are taking a diuretic

Ask A Doctor Or Pharmacist Before Use If You Are

  • •under a doctor’s care for any serious condition •taking any other drug

When Using This Product

  • •avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.

Stop Use And Ask A Doctor If

  • •pain gets worse or lasts more than 21 days •redness or swelling is present in the painful area •fever occurs •skin irritation occurs •any new symptoms appear •you experience any of the following signs of stomach bleeding:ofeel faint ohave bloody or black stools ovomit bloodohave stomach pain that does not get better •you have symptoms of heart problems or stroke:  • chest pain • trouble breathing • leg swelling • weakness in one part or side of body •slurred speech

If Pregnant Or Breast-Feeding,

Ask a health 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.

Directions

  • Use up to 21 days unless directed by your doctorDailyPer DoseFor your arthritis pain:  • Use 4 times per day every day  • Do not use on more than 2 body areas at the same timeUse 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 Consumer 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 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

Other Information

  • •store at 20-25°C (68-77°F). Keep from freezing. •read all product information before using. Keep the dosing card, this box and accompanying leaflet for important information.

Inactive Ingredients

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

Use Enclosed Dosing Card To Measure A Dose

  • How to Use◻For arthritis pain only◻Use 4 times a day◻May take up to 7 days to work for your arthritis pain◻For use on no more than 2 body areas◻Use up to 21 days unless directed by your doctor

* Please review the disclaimer below.