ALIVIO - menthol, capsaicin patch 
Zhejiang Bangli Medical Products 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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Drug Facts

Other Ingredients:

acyrlic acid, aluminum hydroxide, carmellose sodium,

2-ehtylhexyl acrylate, glycerin, isopropyl myristate, methyl

acrylate, nonoxynol - 30, polyacrylate, polyacrylic acid,

poysorbate 80, sorbitan sesquioleate, starch, talc,

tartaric acid, titanium dioxide, water

Active Ingredients

Menthol 5.00 %

Capsaicin 0.03 %

Purpose

External analgesic

Warnings

- For external use only

- Avoid contact with eyes

-Do not apply to open wounds or damages skin

- If symptoms persist for more than seven days, discontinue use and consult a physician

- Keep out of reach of children. If swallowed, consult physician

- Do not bandage tightly

- If pregnant or breast feeding, contact physician prior to use



Keep out of reach of children. If swallowed, consult physician


Uses. For temporary relief of minor aches and pains associated with simply backache, arthritis, strains, bruises  and sprains

-

Directions

-Clean and dry affected area

-Remove patch from backing and apply to affected area. Apply directly to effected area.

-Use only on patch at a time, and a maximum of four patches per day.

-Leave patch on affected area for up to eight hours.

-Do not use patches for more than five consecutive days

-Children under 12 should consult a physician prior to use.

Store at room temperature. A avoid direct sunlight.

copy of label

ALIVIO  
menthol, capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57900-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM400 mg  in 8 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN2.4 mg  in 8 g
Inactive Ingredients
Ingredient NameStrength
ACRYLIC ACID (UNII: J94PBK7X8S)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
METHYL ACRYLATE (UNII: WC487PR91H)  
NONOXYNOL-30 (UNII: JJX07DG188)  
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
STARCH, POTATO (UNII: 8I089SAH3T)  
TALC (UNII: 7SEV7J4R1U)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57900-003-0215 in 1 BOX01/15/201508/01/2016
1NDC:57900-003-018 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 finalpart34801/15/201508/01/2016
Labeler - Zhejiang Bangli Medical Products Co., Ltd (421295875)
Establishment
NameAddressID/FEIBusiness Operations
Zhejiang Bangli Medical Products Co., Ltd421295875manufacture(57900-003)

Revised: 10/2016
 
Zhejiang Bangli Medical Products Co., Ltd