SPL v4
SPL
SPL Set ID 60dce1ad-125e-396d-e053-2a91aa0a670f
Route
TOPICAL
Published
Effective Date 2014-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10 g)
Inactive Ingredients
Aloe Vera Leaf Camphor (natural) Eucalyptus Globulus Leaf Fd&c Blue No. 1 Fd&c Yellow No. 5 Polysorbate 80 Rosmarinus Officinalis Whole Alcohol Simmondsia Chinensis Whole Sorbitan Sesquioleate Steareth-2 Steareth-20 Urea Vitis Vinifera Seed Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-05-06

Description

Menthol 10%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 10%

Uses

TEMPORARILY RELIEVES MINOR PAIN ASSOCIATED WITH:

  • ARTHRITIS
  • SIMPLE BACKACHE
  • MUSCLE STRAINS
  • SPRAINS
Section 51945-4

Warnings

For external use only.

Directions
  • Adults and children 12 years of age and older: Apply a thin layer over the affected area not more than 3 to 4 times daily.
  • Children 12 years of age or younger: Consult a doctor.
  • Close cap tightly after use.
Other Information

Store at controlled room temperature. Do not shake bottle with cap removed.

Active Ingredient:

Menthol 10%

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Camphor, Eucalyptus Globulus Leaf Oil, FD&C Blue #1, FD&C Yellow #5, Polysorbate 80, Rosmarinus Officinalis (Rosemary) Oil, SD 40 Alcohol (5%) Simmondsia Chinensis (Jojoba) Seed Oil, Sorbitan Sesquioleate, Steareth 2, Steareth 20, Urea, Vitis Vinifera (Grape) Seed Extract, Water (Purified)

When Using This Product
  • Use only as directed
  • Do not bandage tighlty or use with a heating pad
  • Avoid contact with eyes and mucous membranes
  • Do not apply to wounds or damaged, broken, or irritated skin.
Questions Or Suggestions?

1.855.763.8733 or visit us at www.thepodiatreecompany.com. Our commitment to you is 100% satisf ication. If you are not completely satisfied, please contact us for a full refund.

Stop Use and Ask A Doctor If
  • Condition worsens
  • Redness is present
  • Irritation develops
  • Symptoms persist for more than 7 days or clear up and reoccur within a few days
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.


Structured Label Content

Uses

TEMPORARILY RELIEVES MINOR PAIN ASSOCIATED WITH:

  • ARTHRITIS
  • SIMPLE BACKACHE
  • MUSCLE STRAINS
  • SPRAINS
Section 51945-4 (51945-4)

Purpose

Topical Analgesic

Warnings

For external use only.

Directions
  • Adults and children 12 years of age and older: Apply a thin layer over the affected area not more than 3 to 4 times daily.
  • Children 12 years of age or younger: Consult a doctor.
  • Close cap tightly after use.
Other Information (Other information)

Store at controlled room temperature. Do not shake bottle with cap removed.

Active Ingredient: (Active ingredient:)

Menthol 10%

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Camphor, Eucalyptus Globulus Leaf Oil, FD&C Blue #1, FD&C Yellow #5, Polysorbate 80, Rosmarinus Officinalis (Rosemary) Oil, SD 40 Alcohol (5%) Simmondsia Chinensis (Jojoba) Seed Oil, Sorbitan Sesquioleate, Steareth 2, Steareth 20, Urea, Vitis Vinifera (Grape) Seed Extract, Water (Purified)

When Using This Product (When using this product)
  • Use only as directed
  • Do not bandage tighlty or use with a heating pad
  • Avoid contact with eyes and mucous membranes
  • Do not apply to wounds or damaged, broken, or irritated skin.
Questions Or Suggestions? (Questions or Suggestions?)

1.855.763.8733 or visit us at www.thepodiatreecompany.com. Our commitment to you is 100% satisf ication. If you are not completely satisfied, please contact us for a full refund.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Condition worsens
  • Redness is present
  • Irritation develops
  • Symptoms persist for more than 7 days or clear up and reoccur within a few days
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.


Advanced Ingredient Data


Raw Label Data

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