Ultimate Topical Pain Relief Patch

Ultimate Topical Pain Relief Patch
SPL v2
SPL
SPL Set ID 33c9f8ba-903e-249e-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (5 g) Capsaicin (0.0375 g)
Inactive Ingredients
Diazolidinyl Urea Edetate Disodium Glycerin Iodopropynyl Butylcarbamate Methylparaben Polysorbate 80 Propylparaben Water Aloe Vera Leaf Sodium Polyacrylate (2500000 Mw)

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-05-01

Description

Menthol 5.00% Capsaicin 0.0375%

Purpose

External Analgesic/Counterirritant External Analgesic/Counterirritant

Dosage and Administration

Ultimate Topical Pain Relief Patch contains 0.0375% capsaicin and 5.00% menthol


Medication Information

Purpose

External Analgesic/Counterirritant External Analgesic/Counterirritant

Dosage and Administration

Ultimate Topical Pain Relief Patch contains 0.0375% capsaicin and 5.00% menthol

Description

Menthol 5.00% Capsaicin 0.0375%

Uses:

Temporarily relieves minor aches and muscle pain associated with simple back ache, arthritis, strains and sprains. Use only as directed.

Purpose:

External Analgesic/Counterirritant

External Analgesic/Counterirritant

Warnings
  • For external useonly.
  • Avoid contact with eyes and mucous membranes.
  • Do not use on wounds or damaged skin.
  • Do not cover with bandage.
  • Do not use if you are allergic to Menthol.
  • Consult physician for use on children under 12.
Directions
  • Adults and children 12 and over apply to affected area; change patch 1 to 2 times daily
  • Children under 12 years: Consult physician before use.
Other Information

Store below 25°C (77°F). Avoid direct sunilght.

Active Ingredients

Menthol 5.00%

Capsaicin 0.0375%

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Diazolidinyl Urea, EDTA Disodium ,Glycerin, Iodopropynyl Butylcarbamate, Methylparaben, Polysorbate 80, Propylparaben, Sodium Polyacrylate, and Water.

Questions Or Comments?

Please call 1-800-290-6816 (Mon-Fri 9AM-5PM CST)

Stop Use and Ask A Doctor If

conditions worsen, if symptoms persist for more than 7 days or clear up and occur again with a few days, or if a rash,

itching or excessive skin irritation occurs.

If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Ultimate Topical Pain Relief Patch


Structured Label Content

Uses:

Temporarily relieves minor aches and muscle pain associated with simple back ache, arthritis, strains and sprains. Use only as directed.

Purpose:

External Analgesic/Counterirritant

External Analgesic/Counterirritant

Warnings
  • For external useonly.
  • Avoid contact with eyes and mucous membranes.
  • Do not use on wounds or damaged skin.
  • Do not cover with bandage.
  • Do not use if you are allergic to Menthol.
  • Consult physician for use on children under 12.
Directions
  • Adults and children 12 and over apply to affected area; change patch 1 to 2 times daily
  • Children under 12 years: Consult physician before use.
Other Information

Store below 25°C (77°F). Avoid direct sunilght.

Active Ingredients

Menthol 5.00%

Capsaicin 0.0375%

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Diazolidinyl Urea, EDTA Disodium ,Glycerin, Iodopropynyl Butylcarbamate, Methylparaben, Polysorbate 80, Propylparaben, Sodium Polyacrylate, and Water.

Questions Or Comments? (Questions or Comments?)

Please call 1-800-290-6816 (Mon-Fri 9AM-5PM CST)

Dosage and Administration

Ultimate Topical Pain Relief Patch contains 0.0375% capsaicin and 5.00% menthol

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

conditions worsen, if symptoms persist for more than 7 days or clear up and occur again with a few days, or if a rash,

itching or excessive skin irritation occurs.

If Pregnant Or Breast Feeding (If pregnant or breast feeding)

ask a health professional before use.

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

If swallowed, get medical help or contact a Poison Control Center right away.

Ultimate Topical Pain Relief Patch


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Raw Label Data

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