SPL v1
SPL
SPL Set ID 3a6d1c1d-49dd-438f-821e-8c885e9cbfcf
Route
TRANSDERMAL
Published
Effective Date 2013-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sulfur (9 mg)
Inactive Ingredients
Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-03-10

Description

external analgesic Uses Releives chronic and acute pain of muscles and joints due to: rheumatic complaints lumbago headache tennis elbow menstrual pain

Purpose

external analgesic Uses Releives chronic and acute pain of muscles and joints due to: rheumatic complaints lumbago headache tennis elbow menstrual pain


Medication Information

Purpose

external analgesic

Uses

Releives chronic and acute pain of muscles and joints due to:

  • rheumatic complaints
  • lumbago
  • headache
  • tennis elbow
  • menstrual pain
Description

external analgesic Uses Releives chronic and acute pain of muscles and joints due to: rheumatic complaints lumbago headache tennis elbow menstrual pain

Dosage
  • adults and children 12 years of age and older: cut up a patch into pieces of desired sizes and apply to affected area. Use up to 10 days.
  • children under 12 years of age: do not use, consult your physician
  • use according to the User Guide inside the package
  • refer to the above warnings; use otherwise than as directed may be dangerous

Other information

Store at room temperature 15° to 30°C (59° to 86°F), away from sunlight.

Warnings

For external use only

If pregnant or breast-feeding, ask a health professional before use

Allergy alert:

This product contains natural rubber latex which may cause allergic reactions.

Do not use

  • on wounds
  • on irritated or damaged skin
  • with a heating pad
  • otherwise than as directed

Stop use and ask a doctor if

  • excessive irritation of the skin develops
  • condition worsens
  • skin rush occurs
Directions

Clean the affected area. Remove the silikon paper film from the patch.

Active Ingredient

sulfur 9 mg

Inactive Ingredient

zinc oxide, on an adhesive bandage backing with a protective paper

Questions Or Comments?

Ph. 1-888-477-5374 M-F 9 am to 5 pm

You may also report serious side effects to this phone number.

Keep Out of Reach of Children

to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.

Motto Analgesic Patch Package


Structured Label Content

Dosage
  • adults and children 12 years of age and older: cut up a patch into pieces of desired sizes and apply to affected area. Use up to 10 days.
  • children under 12 years of age: do not use, consult your physician
  • use according to the User Guide inside the package
  • refer to the above warnings; use otherwise than as directed may be dangerous

Other information

Store at room temperature 15° to 30°C (59° to 86°F), away from sunlight.

Purpose

external analgesic

Uses

Releives chronic and acute pain of muscles and joints due to:

  • rheumatic complaints
  • lumbago
  • headache
  • tennis elbow
  • menstrual pain
Warnings

For external use only

If pregnant or breast-feeding, ask a health professional before use

Allergy alert:

This product contains natural rubber latex which may cause allergic reactions.

Do not use

  • on wounds
  • on irritated or damaged skin
  • with a heating pad
  • otherwise than as directed

Stop use and ask a doctor if

  • excessive irritation of the skin develops
  • condition worsens
  • skin rush occurs
Directions

Clean the affected area. Remove the silikon paper film from the patch.

Active Ingredient (Active ingredient)

sulfur 9 mg

Inactive Ingredient (Inactive ingredient)

zinc oxide, on an adhesive bandage backing with a protective paper

Questions Or Comments? (Questions or Comments?)

Ph. 1-888-477-5374 M-F 9 am to 5 pm

You may also report serious side effects to this phone number.

Keep Out of Reach of Children (Keep out of reach of children)

to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.

Motto Analgesic Patch Package (Motto analgesic patch package)


Advanced Ingredient Data


Raw Label Data

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