Best Choice Cold & Hot Large Medicated Patch

Best Choice Cold & Hot Large Medicated Patch
SPL v1
SPL
SPL Set ID e32e0eca-81d7-7986-e053-2a95a90ae6e1
Route
TOPICAL
Published
Effective Date 2022-07-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (550 mg)
Inactive Ingredients
Petrolatum Sodium Polyacrylate (8000 Mw) Povidone Dihydroxyaluminum Aminoacetate Glycerin Kaolin Methylparaben Carboxymethylcellulose Polysorbate 80 Water Polyethylene Glycol 400 Polyacrylic Acid (8000 Mw) Tartaric Acid Titanium Dioxide Propylparaben Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2022-07-06

Description

Menthol 5%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 5%

Uses

Temporarily relieves minor pain associated with:

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

For external use only

Directions

Adults and children over 12 years:

  • 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: Ask a doctor

Package Label



Best Choice Cold and Hot Large Medicated Patch

Active Ingredient

Menthol 5%

Inactive Ingredients

carboxymethylcellulose, dihydroxyaluminum aminoacetate, glycerin, kaolin, methylparaben, mineral oil, petrolatum, polyacrylic acid, polysorbate 80, propylene glycol, povidone, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, water

Questions Or Comments?

call 1-800-883-0085

Reseal pouch after opening

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
  • do not use if you are allergic to any ingredients of this product
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
  • irritation develops
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 immediately.


Structured Label Content

Uses

Temporarily relieves minor pain associated with:

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

Topical analgesic

Warnings

For external use only

Directions

Adults and children over 12 years:

  • 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: Ask a doctor

Package Label (package label)



Best Choice Cold and Hot Large Medicated Patch

Active Ingredient

Menthol 5%

Inactive Ingredients (Inactive ingredients)

carboxymethylcellulose, dihydroxyaluminum aminoacetate, glycerin, kaolin, methylparaben, mineral oil, petrolatum, polyacrylic acid, polysorbate 80, propylene glycol, povidone, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, water

Questions Or Comments? (Questions or Comments?)

call 1-800-883-0085

Reseal pouch after opening

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
  • do not use if you are allergic to any ingredients of this product
Stop Use and Ask A Doctor If (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
  • irritation develops
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 immediately.


Advanced Ingredient Data


Raw Label Data

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