Perform Cool And Soothing Pain Relieving Roll-on

Perform Cool And Soothing Pain Relieving Roll-on
SPL v7
SPL
SPL Set ID 8af185ad-719e-4684-89c0-9c17c1277499
Route
TOPICAL
Published
Effective Date 2022-02-03
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

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 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.

Drug Facts

Flammable:

Keep away from excessive heat and open flame.

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
Active Ingredients

Menthol 3.5%

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

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Blue 1, Camelia Sinensis Leaf Extract, Carbomer, Citrus Aurantifolia (lime) Oil, Citrus Auratium 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) Kerneol 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 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 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 89 Ml Bottle Label

NDC 59316-112-10

PERFORM ®

MENTHOL-PAIN

RELIEVING

GEL

COOL + SOOTHING

FOR SORE MUSCLES

AND JOINTS

FAST-ACTING

ROLL-ON

3 FL OZ (89 mL)


Structured Label Content

Uses:

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
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.

Drug Facts

Flammable:

Keep away from excessive heat and open flame.

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
Active Ingredients

Menthol 3.5%

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

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Blue 1, Camelia Sinensis Leaf Extract, Carbomer, Citrus Aurantifolia (lime) Oil, Citrus Auratium 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) Kerneol 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:
  • use only as directed
  • Avoid contact with the eyes or 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 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 89 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 89 mL Bottle Label)

NDC 59316-112-10

PERFORM ®

MENTHOL-PAIN

RELIEVING

GEL

COOL + SOOTHING

FOR SORE MUSCLES

AND JOINTS

FAST-ACTING

ROLL-ON

3 FL OZ (89 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)