VOLTAREN ARTHRITIS PAIN- diclofenac sodium gel VOLTAREN ARTHRITIS PAIN- diclofenac sodium kit

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)

Tilgjengelig fra:

Haleon US Holdings LLC

Administreringsrute:

TOPICAL

Resept typen:

OTC DRUG

Indikasjoner:

Arthritis pain reliever - for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body 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. - 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 Voltaren Arthritis Pain. The dosing card is re-usable.

Autorisasjon status:

New Drug Application

Preparatomtale

VOLTAREN ARTHRITIS PAIN- DICLOFENAC SODIUM GEL
VOLTAREN ARTHRITIS PAIN- DICLOFENAC SODIUM
HALEON US HOLDINGS LLC
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_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 inthe 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 th