Cold and Hot Medicated Patch

Cold and Hot Medicated Patch

Drug Labeling and Warnings

Drug Details

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COLD AND HOT MEDICATED PATCH- menthol patch 
Universal Distribution Center LLC

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.

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Cold and Hot Medicated Patch

Active Ingredient

Menthol 5%

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • bursitis
  • tendonitis
  • strains
  • 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 Patch

label

COLD AND HOT MEDICATED PATCH 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 52000-032
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL205.5 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPANEDIOL (UNII: 5965N8W85T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 52000-032-411 in 1 BOX06/21/2017
11 in 1 POUCH; Type 0: Not a Combination Product
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/FEIBusiness Operations
Beijing HKKY Medical Tech. Co., Ltd.544434817manufacture(52000-032)

Revised: 6/2017
 
Universal Distribution Center LLC


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