BENGAY ULTRA STRENGTH

Israel - English - Ministry of Health

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Active ingredient:
CAMPHOR; MENTHOL; METHYL SALICYLATE
Available from:
J-C HEALTH CARE LTD
ATC code:
M02AX10
Pharmaceutical form:
CREAM
Composition:
METHYL SALICYLATE 30 %; MENTHOL 10 %; CAMPHOR 4 %
Administration route:
TOPICAL
Prescription type:
Not required
Manufactured by:
JOHNSON & JOHNSON CONSUMER INC., USA
Therapeutic group:
VARIOUS
Therapeutic area:
VARIOUS
Therapeutic indications:
This medicine is indicated for the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, strains, bruises and sprains.
Authorization number:
133 94 27518 00
Authorization date:
2011-01-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

20-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

22-01-2020

PATIENT PACKAGE INSERT IN ACCORDANCE

WITH THE PHARMACISTS’ REGULATIONS

(PREPARATIONS) - 1986

This medicine is dispensed

without a doctor’s prescription

BenGay

®

Greaseless

Pain Relieving Cream

Cream

Active ingredients - each unit contains:

Methyl Salicylate 15%

Menthol 10%

BenGay

®

Ultra Strength

Cream

Active ingredients - each unit contains:

Methyl Salicylate 30%

Menthol 10%

Camphor 4%

Inactive ingredients and allergens: see section 6

“Further Information”.

Read this leaflet carefully in its entirety before

using this medicine. This leaflet contains concise

information about the medicine. If you have further

questions, refer to the doctor or pharmacist.

The medicine is not intended for conditions similar

to arthritis in infants and children under 12 years of

age. Under this age, refer to a doctor.

Use correctly. Consult a pharmacist if you need

further information. Refer to the doctor if the signs

of the disease )symptoms( worsen or if they do not

improve after 10 days.

1. WHAT IS THIS MEDICINE INTENDED FOR?

This medicine is indicated for the temporary relief of

minor aches and pains of muscles and joints, such

as simple back ache, lumbago, arthritis, strains,

bruises and sprains.

Therapeutic group: Methyl salicylate belongs

to the salicylates group, which are non-steroidal

anti-inflammatory agents.

2. BEFORE USING THE MEDICINE:

Do not use this medicine:

if you are sensitive )allergic( to the active

ingredients or to any of the other ingredients

contained in the medicine.

on damaged skin or on sores.

in children and infants under 12 years of age,

without a doctor’s instructions.

Special warnings regarding use of the

medicine

Excessive use may result in salicylate toxicity

)salicylates have been associated with Reye’s

syndrome(.

Do not use with a heating pad or bandage with

tight dressing.

Avoid contact of the preparation with the eyes. In

case of contact, wash immediately with water.

Avoid contact of the preparation with mucosal

tissues )e.g., the mouth and nose(.

If hyperirritation occurs, stop use. See section 4

“Side Effects”.

Before treatment with BenGay, tell the doctor

if:

you are sensitive to any food or medicine,

especially to salicylates.

you use this medicine frequently or for a prolonged

period.

If you are taking, or have recently taken, other

medicines, including non-prescription medicines

and nutritional supplements, tell the doctor

or pharmacist. Especially inform the doctor or

pharmacist if you are taking:

other preparations containing salicylates )e.g.,

aspirin(: concomitant use may lead to salicylate

poisoning.

anticoagulants,

such

Coumadin:

combination may increase the potential for

bleeding, since BenGay contains salicylate.

Pregnancy and breastfeeding

There is not enough information for safe use

during pregnancy or breastfeeding. Use during

pregnancy and/or breastfeeding must be under

medical supervision.

Driving and use of machinery

This medicine has no effect on ability to drive or

operate machines.

3. HOW SHOULD THE MEDICINE BE USED?

Check with the doctor or pharmacist if you are

uncertain. The usual dosage is generally:

Apply 3-4 times a day, as needed.

Directions for use: Apply a thin layer on the achy

area only and gently massage until the cream

disappears )is absorbed(.

Do not exceed the recommended dose.

Do not swallow! For external use only.

If there is no improvement in your condition within

10 days, refer to a doctor.

If you took an overdose, or if a child accidentally

swallowed the medicine, immediately refer to a

doctor or proceed to a hospital emergency room

and bring the package of the medicine with you.

Do not take medicines in the dark! Check the

label and dose each time you take medicine. Wear

glasses if you need them.

If you have further questions regarding use of the

medicine, consult the doctor or pharmacist.

4. SIDE EFFECTS

As with any medicine, use of BenGay may cause

side effects in some users. Do not be alarmed

when reading the list of side effects. You may not

experience any of them.

Discontinue use and refer to a doctor as soon

as possible, if the following occur:

Irritation )rare(

Rash )rare(

Local inflammation )rare(

Additional side effects

Occurring rarely:

Eyes: ocular irritation

Immune system disorders: angioedema

Respiratory system: shortness of breath

)associated with hypersensitivity(

Application site: skin edema, blisters, burning

sensation, redness, irritation, pain, tingling,

itching, and rash. In addition, urticaria, cold

sensation )BenGay Ultra Strength(

Application site sores or toxicity: burns

If a side effect occurs, if any of the side effects

worsen, if you suffer from a side effect not

mentioned in this leaflet, or if there is a change in

your general feeling, consult the doctor.

Reporting side effects

Side effects can be reported to the Ministry of

Health by clicking on the link “Report Side Effects

of Drug Treatment” found on the Ministry of Health

homepage )www.health.gov.il( that directs you to

the online form for reporting side effects,

or by entering the link:

https://forms.gov.il/globaldata/getsequence/getse

quence.aspx?formType=AdversEffectMedic@moh.

gov.il

5. HOW

SHOULD

THE

MEDICINE

BE

STORED?

Avoid poisoning! This medicine and any other

medicine must be kept in a safe place out of

the reach of children and/or infants to avoid

poisoning. Do not induce vomiting without

explicit instruction from the doctor.

Do not use the medicine after the expiry date

)exp. date( that appears on the package. The

expiry date refers to the last day of that month.

Store in a cool place between 20-25°C.

Store in the original package. Do not store

different medicines in the same package.

6. FURTHER INFORMATION

In addition to the active ingredients, the medicine

also contains:

- BenGay Greaseless Pain Relieving Cream:

Xanthan Gum, Methylparaben, Propylparaben,

Glycerin, Isopropyl Palmitate, Stearic acid, Cetyl

Alcohol, Glyceryl Stearate V, Potassium Cetyl

Phosphate, Potassium Hydroxide, Purified

Water, Phenoxyethanol.

- BenGay Ultra Strength:

Carbomer, Stearic acid, Glyceryl Stearate SE,

Tween 80 )Polysorbate 80(, Lanolin, Trolamine,

Potassium Hydroxide, Edetate Disodium, Purified

Water.

What the medicine looks like and the contents

of the package:

- BenGay Greaseless Pain Relieving Cream:

A plastic tube 2 OZ.

- BenGay Ultra Strength:

A plastic tube 2 OZ, 4 OZ, 6 OZ.

Not all pack sizes may be marketed.

Registration Holder and address:

J-C Health Care Ltd., Kibbutz Shefayim 6099000,

Israel.

Manufacturer and address:

Johnson & Johnson Consumer Inc., NJ, USA.

The format of this leaflet was determined by the

Ministry of Health and its content was checked

and approved in July 2014.

Registration number of the medicine in the National

Drug Registry of the Ministry of Health:

- BenGay Greaseless Pain Relieving Cream:

133-96-23330-00

- BenGay Ultra Strength:

133-94-27518-00

SH Z203000309999B/BNG MAR19

SH Z203000309999B/BNG MAR19

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