Pain Relief Hot Patch

Pain Relief Hot Patch

Drug Labeling and Warnings

Drug Details

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PAIN RELIEF HOT PATCH- menthol and capsaicin 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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Pain Relief Hot Patch

Active Ingredients

Menthol 30 mg

Capsaicin 8.3 mg

Purpose

Topical Analgesic

Topical Analgesic

Uses

Temporarily relieves minor pains associated with:

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle 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:

apply to affected area not more than 3 to 4 times daily

Children under 12 year of age: do not use, consult a doctor
For easy applications: partially peel back protectice film and apply exposed patch to site of pain.
Carefully remove remaining film while pressing patch to skin for secure adhesion.

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL

Pain Relief Hot Patch

label

PAIN RELIEF HOT PATCH 
menthol and capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 52000-034
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL30 mg
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN8.3 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHA PIPERITA (UNII: 79M2M2UDA9)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPANEDIOL (UNII: 5965N8W85T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 52000-034-411 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(52000-034)

Revised: 6/2017
 
Universal Distribution Center LLC


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