Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 75bc6993-cd63-4eba-bdb9-5c5370cc951c
Route
TOPICAL
Published
Effective Date 2011-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (400 mg)
Inactive Ingredients
Acrylic Acid Aluminum Hydroxide Carboxymethylcellulose Sodium Glycerin Isopropyl Myristate Methyl Acrylate Nonoxynol-30 Polysorbate 80 Water Sorbitan Sesquioleate Talc Tartaric Acid Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2011-09-12

Description

Menthol 5%

Purpose

Topical analgesic


Medication Information

Purpose
Topical analgesic

Description

Menthol 5%

Uses
Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • muscle sprains
  • bruises
  • cramps
Warnings

For external use only

Directions
Adults and children over 12 years:

  • carefully remove backing from patch

  • apply sticky side of patch to affected area

  • repeat as necessary, but no more than 4 times daily
Package Label


Best Choice Cold and Hot Small Medicated Patch
Active Ingredient
Menthol 5%

Inactive Ingredients

2-ethylhexyl acrylate, acrylic acid, aluminium hydroxide, carboxymethylcellulose sodium, glycerin, isopropyl myristate, methyl acrylate, nonoxynol-30, polyacrylic acid, polysorbate 80, purified water, sodium polyacrylate, sorbitan sesquioleate, starch, talc, tartaric acid, titanium oxide

When Using This Product
  • use only as directed
  • do not bandage tightly or use with heating pad

  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin
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 occur again within a few days
If Pregnant Or Breast Feeding,
ask a health professional before use.

Keep Out of Reach of Children.

For use on children 12 years or younger consult a doctor. Do not use on infants. If swallowed, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Uses
Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • muscle sprains
  • bruises
  • cramps
Purpose
Topical analgesic

Warnings

For external use only

Directions
Adults and children over 12 years:

  • carefully remove backing from patch

  • apply sticky side of patch to affected area

  • repeat as necessary, but no more than 4 times daily
Package Label (package label)


Best Choice Cold and Hot Small Medicated Patch
Active Ingredient
Menthol 5%

Inactive Ingredients (Inactive ingredients)

2-ethylhexyl acrylate, acrylic acid, aluminium hydroxide, carboxymethylcellulose sodium, glycerin, isopropyl myristate, methyl acrylate, nonoxynol-30, polyacrylic acid, polysorbate 80, purified water, sodium polyacrylate, sorbitan sesquioleate, starch, talc, tartaric acid, titanium oxide

When Using This Product (When using this product)
  • use only as directed
  • do not bandage tightly or use with heating pad

  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin
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 occur again 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.)

For use on children 12 years or younger consult a doctor. Do not use on infants. If swallowed, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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