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PainKoolers Topical Analgesic

Medically reviewed on Nov 30, 2017

Dosage form: gel
Ingredients: MENTHOL, UNSPECIFIED FORM 5g in 100g, CAPSAICIN 0.05g in 100g
Labeler: GA Health and Beauty (FOSHAN) Co., Ltd
NDC Code: 70118-002

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

DRUG FACTS:

ACTIVE INGREDIENTS:

Menthol  5.00%

Capsaicin  0.05%

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 muccous membranes.

Do not cover ​with bandage

Do not use

on wounds or damaged skin • ​ Do not use ​in combination with any other external analgesic products • Avoid contact with eyes and maccous membranes •  ​Do not use ​in combination with any external heat source. • ​ Do not use ​on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment

Keep out of reach of children

• Consult physician for children under 12

• Do not use

if you are allergic or amenthol

• Stop use

and ask a doctor id 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.

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 protected 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

INACTIVE INGREDIENTS:

Purified Water,Glycerin,Polyvinyl Alcohol,Sodium Polyacrylate,Propylene Glycol,Polysorbate 80,Sorbitan Stearate,Aloe Barbadensis leaf (Aloe Vera Gel) Juice, Aanica Montana Extract, Rosemary Oil,Tartaric Acid,Dihydroxyaluminum Aminoacetate,Titanium Dioxide,Kaolin,Glydant Plus Liquid.

Package Labeling:

PAINKOOLERS TOPICAL ANALGESIC 
menthol, unspecified form, capsaicin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70118-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (MENTHOL) MENTHOL, UNSPECIFIED FORM5 g  in 100 g
CAPSAICIN (CAPSAICIN) CAPSAICIN0.05 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
POLYVINYL ALCOHOL 
PROPYLENE GLYCOL 
POLYSORBATE 80 
SORBITAN MONOSTEARATE 
ALOE VERA LEAF 
ARNICA MONTANA 
ROSEMARY OIL 
TARTARIC ACID 
DIHYDROXYALUMINUM AMINOACETATE 
TITANIUM DIOXIDE 
KAOLIN 
Packaging
#Item CodePackage Description
1NDC:70118-002-055 PATCH in 1 POUCH
18 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/21/2015
Labeler - GA Health and Beauty (FOSHAN) Co., Ltd (544333811)
Establishment
NameAddressID/FEIOperations
GA Health and Beauty (FOSHAN) Co., Ltd544333811repack(70118-002), relabel(70118-002)

 
GA Health and Beauty (FOSHAN) Co., Ltd

Further information

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

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