PAIN RELIEF PATCH- menthol,capsaicin,menthyl salicylate patch 
Hangzhou Jujiu Science & Biotechnology 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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cold& hot patch

Active Ingredient

Menthyl salicylate 5.00% 
Menthol 5.00% 
Capsaicin 0.025% 

Purpose

Topical analgesic

Use

 Arthritis
 simple backache
 strains
 sprains
 bursitis
 tendonitis
 bruises
 cramps

Warnning

Do not apply wounds or damaged skin.
Do not bandage this product or cover with anything other than light clothing
Avoid contact with eyes or mucous membranes.
Ask a doctor or pharmacist before use if you are
 allergic to salicylates
 taking anticoagulant medications .
When using this product
 For external use only, to relieve the temporary pain.
The application of external heat, such as a heating pad may result in excessive skin irritation or skin burn.
Stop use and ask a doctor if
 rash, irritation, excessive redness, burning or discomfort of the skin develop.
 condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product with any other heating or cooling device or with other external analgesic products.

Keep out of reach of children, Children 12 years of age and under should only use this product upon the advice of a healthcare practitioner.

Directions

 Adults: Apply Pain relief patch to the affected area not more than 3 to 4 times daily.
 For children under 12 years of age, consult your health care practitioner.
 Open pouch and remove patch.
 If desired, cut patch to size.
 Peel off protective film and apply sticky side to desired area.
 Remove patch before applying a new one.
 Dispose of patch in waste receptacle.
 If condition worsens, of if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a healthcare practitioner.

Inactive Ingredients

Aluminium glycinate, Ethylene Diamine Tetraacetic Acid, Polysorbate 80, Titanium dioxide, Purified water, Tartaric acid, Glycerin, Sodium polyacrylate, Carbomer, Sodium carboxymethyl cellulose

image description

PAIN RELIEF PATCH 
menthol,capsaicin,menthyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69963-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (SALICYLIC ACID - UNII:O414PZ4LPZ) MENTHYL SALICYLATE, (+/-)-5 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALUMINIUM TRIGLYCINATE (UNII: 5TLG1CL557) 0.025 g  in 100 g
DIAMINOHYDROXYPROPANETETRAACETIC ACID (UNII: 949B9ZMO7M) 0.025 g  in 100 g
POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.025 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 0.025 g  in 100 g
WATER (UNII: 059QF0KO0R) 0.025 g  in 100 g
TARTARIC ACID (UNII: W4888I119H) 0.025 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 0.025 g  in 100 g
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) 0.025 g  in 100 g
CARBOMER 940 (UNII: 4Q93RCW27E) 0.025 g  in 100 g
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) 0.025 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69963-001-015 in 1 POUCH01/08/2018
10.5 g in 1 KIT; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/10/2015
Labeler - Hangzhou Jujiu Science & Biotechnology Co.,Ltd. (543207110)
Registrant - Hangzhou Jujiu Science & Biotechnology Co.,Ltd. (543207110)
Establishment
NameAddressID/FEIBusiness Operations
Hangzhou Jujiu Science & Biotechnology Co.,Ltd.543207110manufacture(69963-001)

Revised: 1/2018
Document Id: 62180579-6f87-6a2c-e053-2a91aa0aa2ec
Set id: 4155cff9-27ca-448e-af85-c1bdfe26f744
Version: 3
Effective Time: 20180106
 
Hangzhou Jujiu Science & Biotechnology Co.,Ltd.