Cold and hot medicated patch

Active ingredient

Menthol 5%

Purpose

Menthol - Topical analgesic

Uses

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

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

Warnings

When using this product

  • use only as directed
  • avoid contact with eyes or on 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

  • excessive redness or irritation is present
  • condition worsens
  • pain persist for more than 7 days
  • symptoms 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.

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

Directions

  • adults and children 12 years and over: apply patch to affected area as needed but not more than 4 times daily
  • children under 12 years: ask a doctor
  • for easy application; grasp both ends of pad firmly, pull at both ends. Stretch pad until the backing separates. Remove protective film while applying pad directly to site of pain.

Inactive ingredients

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

Ingredients and appearance - Product information

Cold and hot medicated patch- Menthol

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 14785-8117
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Menthol, unspecified form ( UNII: L7T10EIP3A)( Menthol - UNII: L7T10EIP3A ) 50 mgin 1

Inactive Ingredients

Ingredient Name Code
Carboxymethylcellulose sodium, unspecified form ( UNII: K679OBS311)
Dihydroxyaluminum aminoacetate ( UNII: DO250MG0W6)
Edetate disodium ( UNII: 7FLD91C86K)
Glycerin ( UNII: PDC6A3C0OX)
Isopropyl myristate ( UNII: 0RE8K4LNJS)
Polyvinyl alcohol, unspecified ( UNII: 532B59J990)
Polyacrylic acid (250000 mw) ( UNII: 9G2MAD7J6W)
Polysorbate 80 ( UNII: 6OZP39ZG8H)
Water ( UNII: 059QF0KO0R)
Sorbitan sesquioleate ( UNII: 0W8RRI5W5A)
Sorbitol ( UNII: 506T60A25R)
Talc ( UNII: 7SEV7J4R1U)
Tartaric acid ( UNII: W4888I119H)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part348 USA

Labeler - Mentholatum China Pharmaceutical Co. Ltd.( 420786030)

Package/label principal display panel

Cold and Hot Medicated Patch Menthol 5% (Large)

Package/label principal display panel

Cold and Hot Medicated Patch Menthol 5% (Small)