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NDC 51316-0012-15 Arthritis Pain Reliever 10 mg/g Details

Arthritis Pain Reliever 10 mg/g

Arthritis Pain Reliever is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by CVS PHARMACY, INC. The primary component is DICLOFENAC SODIUM.

MedlinePlus Drug Summary

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 medications called nonsteroidal anti-inflammatory drugs (NSAIDs). The way diclofenac gel works to treat actinic keratosis is not known. Diclofenac is also available as a liquid (Pennsaid) and a gel (Voltaren) that are applied to the skin to treat arthritis pain. This monograph only gives information about diclofenac gel (Solaraze) for actinic keratosis. If you are using either of the products for osteoarthritis, read the monograph entitled diclofenac topical (osteoarthritis pain).

Related Packages: 51316-0012-15
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Diclofenac Topical (actinic keratosis)

Product Information

NDC	51316-0012
Product ID	51316-012_5a104d37-c640-4bb9-9daa-b271ca63789b
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Arthritis Pain Reliever
Proprietary Name Suffix	n/a
Non-Proprietary Name	Diclofenac sodium
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	10
Active Ingredient Units	mg/g
Substance Name	DICLOFENAC SODIUM
Labeler Name	CVS PHARMACY, INC
Pharmaceutical Class	Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA208077
Listing Certified Through	2024-12-31

Package

Package Images

NDC 51316-0012-15 (51316001215)

Pricing Information	N/A
NDC Package Code	51316-012-15
Billing NDC	51316001215
Package	1 TUBE in 1 CARTON (51316-012-15) / 150 g in 1 TUBE
Marketing Start Date	2022-02-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 047985ea-f768-4f9a-bfe3-0acf40a4781d Details

Active ingredient

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

*nonsteroidal anti-inflammatory drug

Purpose

Arthritis Pain Reliever

Uses

for 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 no pain relief in 7 days, stop use

Warnings

For external use only.

Allergy 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
rash

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:

more or for a longer time than directed
when using other drugs containing diclofenac

Stomach 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 directed

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 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.

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:

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 areas as any other product
do not apply with external heat such as a heating pad
do not apply a bandage over the treated area
store ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1%. The dosing card is re-usable.

Other information

store at 20° to 25°C (68° to 77°F). Keep from freezing.
read all product information before using. Keep the dosing card, this carton and accompanying User Guide 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

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

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 a doctor

Principal display panel

COMPARE TO the active ingredient in Voltaren® Arthritis Pain Topical Gel†

ORIGINAL PRESCRIPTION STRENGTH

Diclofenac Sodium

Topical Gel, 1%

(NSAID) ARTHRITIS PAIN RELIEVER

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 GSK Consumer Healthcare, distributor of Voltaren® Arthritis Pain Topical Gel.

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

Package Label

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

CVS HEALTH Arthritis Pain Reliever

INGREDIENTS AND APPEARANCE

ARTHRITIS PAIN RELIEVER

diclofenac sodium gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51316-012
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)	DICLOFENAC SODIUM	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51316-012-15	1 in 1 CARTON	02/04/2022
1		150 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208077	02/04/2022

Labeler - CVS PHARMACY, INC (062312574)

Revised: 2/2022

Document Id: 5a104d37-c640-4bb9-9daa-b271ca63789b

Set id: 047985ea-f768-4f9a-bfe3-0acf40a4781d

Version: 1

Effective Time: 20220215