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Cold and Hot Medicated Large

Medically reviewed on June 20, 2017

Dosage form: patch
Ingredients: MENTHOL 428.5mg
Labeler: Universal Distribution Center LLC
NDC Code: 52000-033

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Cold and Hot Medicated Large Patch

Active Ingredient

Menthol 5%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints due to:

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

Warnings

For external use only.

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.

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.

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 of age and older:

protective backing and apply sticky side to affected area

  • carefully remove backing from patch.
  • should be used up to 8 hours.
  • should be used no more than 3 times a day.

Children Under 12 Years of Age: consult a doctor.

Other information

  • store at room temperature, not to exceed 86°F(30°C).

Inactive Ingredients

aluminum hydroxide, camphor, eucalyptus oil, glycerin, methylparaben, polyacrylic acid, propanediol, propylparaben, purified water.

PRINCIPAL DISPLAY PANEL

Cold and Hot Medicated Large Patch

COLD AND HOT MEDICATED LARGE 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-033
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL428.5 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE 
CAMPHOR (SYNTHETIC) 
EUCALYPTUS OIL 
GLYCERIN 
METHYLPARABEN 
PROPANEDIOL 
PROPYLPARABEN 
WATER 
Packaging
#Item CodePackage Description
1NDC:52000-033-411 POUCH in 1 BOX
11 PATCH in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/21/2017
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Universal Distribution Center LLC (019180459)
Establishment
NameAddressID/FEIOperations
Beijing HKKY Medical Tech. Co., Ltd.544434817manufacture(52000-033)

 
Universal Distribution Center LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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