ASPERCREME ARTHRITIS- diclofenac sodium gel 
Chattem, Inc.

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Aspercreme Arthritis - ENCUBE

Drug Facts

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 age 18 years. It is not known if this drug works or is safe in children under age 18 years.

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, 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 or side of body

    slurred speech

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to 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 right away (1-800-222-1222).

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.

DailyPer 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 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 Aspercreme Arthritis Pain. The dosing card is re-usable.

Other information

 store at 20-25°C (68-77°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, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution

Questions?

Call 1-866-844-2798 or visit www.Aspercreme.com

PRINCIPAL DISPLAY PANEL

NDC 41167-0571-1
Aspercreme
ARTHRITIS PAIN
DICLOFENAC SODIUM
TOPICAL GEL, 1% (NSAID)
NET WT 3.53 OZ (100g)

NDC 41167-0571-1
Aspercreme 
ARTHRITIS PAIN
DICLOFENAC SODIUM 
TOPICAL GEL, 1% (NSAID)
NET WT 3.53 OZ (100g)

ASPERCREME ARTHRITIS 
diclofenac sodium gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0571
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC SODIUM0.01 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
COCOYL CAPRYLOCAPRATE (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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0571-01 in 1 CARTON02/01/2024
150 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:41167-0571-11 in 1 CARTON02/01/2024
2100 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21098602/01/2024
Labeler - Chattem, Inc. (003336013)

Revised: 10/2023
Document Id: dd16cfea-a7f0-47cc-84aa-6681297b92ce
Set id: 81f78685-c416-48b5-8840-eef03a66bc28
Version: 1
Effective Time: 20231011
 
Chattem, Inc.