Menthol 5% (topical Analgesic)

Menthol 5% (topical Analgesic)
SPL v5
SPL
SPL Set ID f833dd00-0c87-435f-a2e3-7b0d63e0ea1d
Route
TOPICAL
Published
Effective Date 2013-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (.05 mg)
Inactive Ingredients
Aloe Vera Leaf Aluminum Hydroxide Edetate Disodium Gelatin Kaolin Methylparaben Glycerin Titanium Dioxide Isopropyl Myristate Water Peg-4 Stearate Polyvinyl Alcohol Polysorbate 80 Alpha-tocopherol Acetate Silodrate Castor Oil Tartaric Acid Butylated Hydroxytoluene

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-08-15

Description

Active ingredient Menthol 5%


Medication Information

Warnings and Precautions

Warnings

  • For external use only
  • If pregnant or breast-feeding, ask a health professional before use.

Indications and Usage

Uses

Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • muscle sprains
  • bruises
  • cramps
Dosage and Administration

Directions

adults and children 12 years of age and older

  • peel off protective backing and apply sticky side to affected area
  • carefully remove backing from patch
  • apply one patch to affected area
  • repeat as necessary, but no more than 4 times daily

children under 12 years of age consult a doctor

Description

Active ingredient Menthol 5%

Section 44425-7

Other information

  • store at room temperature

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • skin irritation develops
Section 50567-7

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin

Section 51727-6

Inactive ingredients

aloe barbadensis leaf juice, alumina magnesium metasilicate, aluminum hydroxide, BHT, castor oil, disodium EDTA, gelatin, glycerin, isopropyl myristate, kaolin, methylparaben, PEG-4 stearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate

Section 51945-4




Section 53413-1

Questions or comments? 1-800-WALGREENS (1-800-925-4733)

Section 55105-1

Purpose

Topical Analgesic

Section 55106-9

Active ingredient

Menthol 5%


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • muscle sprains
  • bruises
  • cramps
Dosage and Administration (34068-7)

Directions

adults and children 12 years of age and older

  • peel off protective backing and apply sticky side to affected area
  • carefully remove backing from patch
  • apply one patch to affected area
  • repeat as necessary, but no more than 4 times daily

children under 12 years of age consult a doctor

Warnings and Precautions (34071-1)

Warnings

  • For external use only
  • If pregnant or breast-feeding, ask a health professional before use.

Section 44425-7 (44425-7)

Other information

  • store at room temperature

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 50566-9 (50566-9)

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • skin irritation develops
Section 50567-7 (50567-7)

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin

Section 51727-6 (51727-6)

Inactive ingredients

aloe barbadensis leaf juice, alumina magnesium metasilicate, aluminum hydroxide, BHT, castor oil, disodium EDTA, gelatin, glycerin, isopropyl myristate, kaolin, methylparaben, PEG-4 stearate, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate

Section 51945-4 (51945-4)




Section 53413-1 (53413-1)

Questions or comments? 1-800-WALGREENS (1-800-925-4733)

Section 55105-1 (55105-1)

Purpose

Topical Analgesic

Section 55106-9 (55106-9)

Active ingredient

Menthol 5%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)