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PainKoolers Topical Analgesic Patch

Medically reviewed on September 22, 2017.

Dosage form: patch
Ingredients: MENTHOL 5g in 1g, CAPSAICIN 0.05g in 1g
Labeler: GA Health and Beauty (FOSHAN) Co., Ltd
NDC Code: 70118-001

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.

PainKoolers Topical Analgesic Patch

ACTIVE INGREDIENTS:

Menthol 5.00%
Capsaicin 0.05%

Analgesic/Counterirritant
External Analgesic

USES:

For the temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, sprains, bruises and strains.

WARNINGS:

For external use only.

  • Use only as directed. Avoid contact with eyes and mucous membranes.
  • Do not cover with bandage.
  • Do not use on wounds or damaged skin.
  • Do not use if you are allergic to Menthol.
  • Stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days.
  • Or Rash, itching or excessive skin irritation occurs.

Keep out of reach of children.

Consult Physician for children under 12.

DIRECTIONS:
  • Adults and children 12 years and over apply to affected area.
  • Change patch 1 to 2 times daily.
  • Children under 12 years, consult physician before use.

How to apply:

Clean and dry affected area
Cut open pouch and remove patch
Remove protective film and apply directly to area of pain
Apply to affected area not more than 3 times daily
Wash hands with soap after applying patch
Reseal pouch containing unused patches

OTHER INGREDIENTS:

Water, Glycerine, Sodium Polyacrylate, Polyscorbate 80, Aloe Barbadesis Leaf (Aloe Vera Gel) Juice, EDTA Disodium salt, Diaxolidinyl Urea, Methylparaben, Iodoproynyl Butylcarbamate, Propylparaben.

Package Label

PAINKOOLERS TOPICAL ANALGESIC PATCH 
menthol and capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70118-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL5 g  in 1 g
CAPSAICIN (CAPSAICIN) CAPSAICIN0.05 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
SODIUM POLYACRYLATE (2500000 MW) 
POLYSORBATE 80 
ALOE VERA LEAF 
EDETATE DISODIUM 
DIAZOLIDINYL UREA 
METHYLPARABEN 
IODOPROPYNYL BUTYLCARBAMATE 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:70118-001-055 PATCH in 1 POUCH
18 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/21/2015
Labeler - GA Health and Beauty (FOSHAN) Co., Ltd (544333811)

 
GA Health and Beauty (FOSHAN) Co., Ltd

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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