ARTHRITIS PAIN RELIEVER- diclofenac sodium gel 
AmerisourceBergen (Good Neighbor Pharmacy) 46122

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Diclofenac Sodium 1 percent Gel AML

Active ingredient

Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac)

*nonsteroidal anti-inflammatory drug

Purpose

Arthritis Pain Reliever

Uses

Warnings

For external use only.

Allergy alert: Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

If 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:

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is small but higher if you:

Heart 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 or to a fever reducer
  • for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of 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
  • you are under the age of 18 years. It is not known if this drug works or is safe in children under the age of 18 years.

Ask a doctor or pharmacist before use if

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

When using this product

  • avoid contact with eyes, nose, or mouth
  • 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. These could be signs of a serious condition.
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • have bloody or black stools
    • vomit blood
    • have 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 of side of body
    • slurred speech

If pregnant or breast-feeding,

ask a health professional before use. It is especially important to not use diclofenac at  20 weeks or later in  pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children

 If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

Directions

Use up to 21 days unless directed by your doctor. Not for strains, sprains, bruises or sports injuries.This product has not been shown to work for these types of injuries.

 Daily Per Dose

 For your arthritis pain:

  • Use 4 times per day every day
  • Do not use on more than 2 body areas at the same time

 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:


Other 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

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9 AM- 5 PM EST

Med Guide

Use enclosed dosing card to measure a dose

Diclofenac Sodium Topical Gel, 1% (NSAID) - arthritis pain reliever

[Upper body dose 2.25 inches long (2 grams)] Dosing Card (NOT ACTUAL SIZE)

[Lower body dose 4.5 inches long (4 grams) Read product User Guide before use Not for immediate pain relief

How to use

Principal display panel

Compare to Voltaren® Arthritis Pain Topical Gel active ingredient†

Diclofenac Sodium Topical Gel, 1%

(NSAID) Arthritis Pain Reliever

Original prescription strength

Medicated gel clinically proven to relieve arthritis pain

For daily treatment of arthritis pain

Anti-inflammatory

For External Use only

NET WT OZ (g)

†This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, distributor of Voltaren® Arthritis Pain Topical Gel.

TAMPER EVIDENT STATEMENT: DO NOT USE IF FOIL SEAL ON TUBE OPENING IS BROKEN OR MISSING.

Manufactured by:

Amneal Pharmaceuticals LLC

Piscataway, NJ 08854

Distributed by: AmerisourceBergen

1 West First Avenue, Conshohocken, PA 19428

Package Label

Diclofenac Sodium (NSAID*) 1% (equivalent to 0.93% diclofenac) *nonsteroidal anti-inflammatory drug

GOOD NEIGHBOR PHARMACY Arthritis Pain Reliever

ARTHRITIS PAIN RELIEVER 
diclofenac sodium gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-752
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC SODIUM10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (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)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46122-752-531 in 1 CARTON04/01/2023
1150 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:46122-752-371 in 1 CARTON04/01/2023
250 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:46122-752-521 in 1 CARTON04/01/2023
3100 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20807704/01/2023
Labeler - AmerisourceBergen (Good Neighbor Pharmacy) 46122 (007914906)

Revised: 8/2023
Document Id: 64583277-4362-4eeb-90a9-e22d75377ff4
Set id: 30e1f589-b322-48b7-9a97-502afe2a1baa
Version: 5
Effective Time: 20230809
 
AmerisourceBergen (Good Neighbor Pharmacy) 46122