PAINKOOLERS TOPICAL ANALGESIC- menthol, unspecified form, capsaicin gel 
GA Health and Beauty (FOSHAN) Co., Ltd

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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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:

How to apply:

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:

label

PAINKOOLERS TOPICAL ANALGESIC 
menthol, unspecified form, capsaicin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70118-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.05 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA (UNII: O80TY208ZW)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
TARTARIC ACID (UNII: W4888I119H)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
KAOLIN (UNII: 24H4NWX5CO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70118-002-055 in 1 POUCH
18 g in 1 PATCH; Type 0: Not a Combination Product
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/FEIBusiness Operations
GA Health and Beauty (FOSHAN) Co., Ltd544333811repack(70118-002) , relabel(70118-002)

Revised: 11/2015
Document Id: 25c58c92-0362-0e8e-e054-00144ff8d46c
Set id: d9e8b5c9-3c40-4917-ad56-5a38153ffa7e
Version: 2
Effective Time: 20151130
 
GA Health and Beauty (FOSHAN) Co., Ltd