drug facts

drug facts
SPL v4
SPL
SPL Set ID 13565b05-ce32-444c-8765-cda23b0036fc
Route
topical
Published
Effective Date 2016-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (50 mg)
Inactive Ingredients
carboxymethylcellulose sodium, unspecified form dihydroxyaluminum aminoacetate edetate disodium 2-ethylhexyl acrylate glycerin isopropyl myristate methyl acrylate polyacrylic acid (250000 mw) polysorbate 80 polyvinyl alcohol, unspecified water sorbitan sesquioleate sorbitol talc tartaric acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2017-02-06

Purpose

Menthol - Topical Analgesic

Description

Menthol 5%


Medication Information

Warnings

For external use only

Uses

temporarily relieves minor aches and pains of muscles and joints due to

  • simple backache
  • arthritis
  • strains
  • sprains
Purpose

Menthol - Topical Analgesic

Directions
  • adults and children 12 years and over: apply to affected area; change patch 1 to 2 times daily
  • children under 12 years: ask a doctor
  • FOR BEST RESULTS apply to clean, dry skin
  • tear open pouch and remove patch; if desired, cut patch to size
  • grasp both ends of the patch firmly with thumbs near center
  • stretch patch until the backing separates
  • remove protective film while applying patch directly to site of pain
Inactive Ingredients

carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, ethylhexyl acrylate, glycerin, isopropyl myristate, partially neutralized polyacrylate, polyacrylic acid, polymethyl acrylate, polysorbate 80, polyvinyl alcohol, purified water, sodium polyacrylate starch, sorbeth-60 tetraoleate, sorbitan sesquioleate, sorbitol solution, talc, tartaric acid

Description

Menthol 5%

Principal Display Panel
Questions?

1-877-636-2677 MON - FRI 9AM to 5PM (EST)

www.wellpatch.com

Active Ingredient

Menthol 5%

When Using This Product
  • use only as directed
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or to damaged or very sensitive skin
  • do not bandage tightly or use with a heating pad
Stop Use and Ask A Doctor If
  • condition worsens
  • excessive redness, irritation, burning, or discomfort of the skin develops
  • pain persists for more than 7 days
  • symptoms clear up and occur again within a few days
Keep Out of Reach of Children.

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

Package/label Principal Display Panel

Structured Label Content

Warnings

For external use only

Uses

temporarily relieves minor aches and pains of muscles and joints due to

  • simple backache
  • arthritis
  • strains
  • sprains
Purpose

Menthol - Topical Analgesic

Directions
  • adults and children 12 years and over: apply to affected area; change patch 1 to 2 times daily
  • children under 12 years: ask a doctor
  • FOR BEST RESULTS apply to clean, dry skin
  • tear open pouch and remove patch; if desired, cut patch to size
  • grasp both ends of the patch firmly with thumbs near center
  • stretch patch until the backing separates
  • remove protective film while applying patch directly to site of pain
Inactive Ingredients (Inactive ingredients)

carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, ethylhexyl acrylate, glycerin, isopropyl myristate, partially neutralized polyacrylate, polyacrylic acid, polymethyl acrylate, polysorbate 80, polyvinyl alcohol, purified water, sodium polyacrylate starch, sorbeth-60 tetraoleate, sorbitan sesquioleate, sorbitol solution, talc, tartaric acid

Principal Display Panel
Questions?

1-877-636-2677 MON - FRI 9AM to 5PM (EST)

www.wellpatch.com

Active Ingredient (Active ingredient)

Menthol 5%

When Using This Product (When using this product)
  • use only as directed
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or to damaged or very sensitive skin
  • do not bandage tightly or use with a heating pad
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • excessive redness, irritation, burning, or discomfort of the skin develops
  • pain persists for more than 7 days
  • symptoms clear up and occur again within a few days
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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data


Raw Label Data

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