Perform ®

Perform ®
SPL v8
SPL
SPL Set ID ef158f63-2d75-47a3-b94a-2d821d511863
Route
TOPICAL
Published
Effective Date 2022-02-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (35 mg)
Inactive Ingredients
Aloe Vera Leaf Arnica Montana Flower Fd&c Blue No. 1 Green Tea Leaf Lime Oil, Cold Pressed Orange Oil, Cold Pressed Eucalyptus Oil Glycerin Hypericum Oil Ilex Paraguariensis Leaf Isopropyl Alcohol Lavandin Oil Peppermint Oil Nutmeg Oil Pine Needle Oil (pinus Sylvestris) Polysorbate 20 Silicon Dioxide Thyme Oil Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-05-18 Until 2023-12-31

Description

Menthol 3.5%

Purpose

Pain Relieving Gel


Medication Information

Purpose

Pain Relieving Gel

Description

Menthol 3.5%

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 42229-5

Dist. by: RB Health (US), Parsippany, NJ 07054-0224

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 53414-9

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

Warnings

​For external use only.

Directions
  • adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a physician
  • wash hands after use with cool water
Flammable:

Keep away from excessive heat or open flame

Active Ingredient

Menthol 3.5%

Other Information
  • store at 20-25°C (68-77°F)
  • store in a cool dry place away from direct sunlight
Inactive Ingredients

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Blue 1, Camellia Sinensis Leaf Extract, Carbomer, Citrus Aurantifolia (Lime) Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Eucalyptus Globulus Leaf Oil, Glycerin, Hypericum Perforatum Oil, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Lavandula Hybrida Oil, Mentha Piperita (Peppermint) Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Pinus Sylvestris Leaf Oil, Polysorbate 20, Silica, Thymus Vulgaris (Thyme) Flower/Leaf Oil, Triethanolamine, Water

Questions Or Comments?

1-800-246-3733

When Using This Product
  • use only as directed
  • avoid contact with the eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage tightly or use with heating pad or device
Stop Use and Ask A Doctor If
  • you experience pain, swelling or blistering of the skin
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age
Principal Display Panel 118 Ml Tube Label

NDC 59316-111-20

PERFORM ®

MENTHOL-PAIN

RELIEVING

GEL

COOL + SOOTHING

FOR SORE MUSCLES

AND JOINTS

FAST-ACTING

4 FL OZ (118 mL)


Structured Label Content

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 42229-5 (42229-5)

Dist. by: RB Health (US), Parsippany, NJ 07054-0224

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 53414-9 (53414-9)

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

Purpose

Pain Relieving Gel

Warnings

​For external use only.

Directions
  • adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a physician
  • wash hands after use with cool water
Flammable:

Keep away from excessive heat or open flame

Active Ingredient (Active ingredient)

Menthol 3.5%

Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • store in a cool dry place away from direct sunlight
Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Blue 1, Camellia Sinensis Leaf Extract, Carbomer, Citrus Aurantifolia (Lime) Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Eucalyptus Globulus Leaf Oil, Glycerin, Hypericum Perforatum Oil, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Lavandula Hybrida Oil, Mentha Piperita (Peppermint) Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Pinus Sylvestris Leaf Oil, Polysorbate 20, Silica, Thymus Vulgaris (Thyme) Flower/Leaf Oil, Triethanolamine, Water

Questions Or Comments? (Questions or comments?)

1-800-246-3733

When Using This Product (When using this product)
  • use only as directed
  • avoid contact with the eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage tightly or use with heating pad or device
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you experience pain, swelling or blistering of the skin
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • arthritic pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age
Principal Display Panel 118 Ml Tube Label (PRINCIPAL DISPLAY PANEL - 118 mL Tube Label)

NDC 59316-111-20

PERFORM ®

MENTHOL-PAIN

RELIEVING

GEL

COOL + SOOTHING

FOR SORE MUSCLES

AND JOINTS

FAST-ACTING

4 FL OZ (118 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)