BIO-SORB- capsaicin cream 
Sircle Laboratories, LLC

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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Bio-Sorb

Drug Facts

Active ingredients

Capsaicin 0.025% w/w (Containing Capsicum Oleoresin 0.0625%)

Purpose

Topical Analgesic

Uses

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

Warnings

For external use only

When using this product

  • Do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rise with cool water and seek medical help.

Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Stop using and get immediate medical attention if experience burning, pain, swelling or blistering of the skin. Rare cause of severe burning or blistering have been reported.

If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use.

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away. If inhaled, remove to fresh air. If breathing is difficult, get medical attention immediately.

Directions

Inactive ingredients

Aloe Barbadensis Leaf Extract, Bisabolol, Carbomer, Caprylyl Glycol, Cetearyl Alcohol, Ceteareth-20, Green Tea (Camellia Sinensis) Leaf Extract, Glycerin, Methylisothiazolinone, PEG-8, Polyglyceryl-3 Oleate, Triethanolamine, Water.

Questions or comments?

Call toll-free 1-888-452-9975; www.sirclelabs.com

PRINCIPAL DISPLAY PANEL - 237 ml Bottle Label

NDC 51021-0302-08

BIO-SORB
Cream

Capsaicin 0.025%

Topical Use Only

SIRCLE
Laboratories

8 fl oz (237ml)

Principal Display Panel - 237 ml Bottle Label
BIO-SORB 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51021-302
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
LEVOMENOL (UNII: 24WE03BX2T)  
POLYETHYLENE GLYCOL 800 (UNII: UH6KR4953D)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51021-302-08237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/20/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/20/2018
Labeler - Sircle Laboratories, LLC (962175621)
Establishment
NameAddressID/FEIBusiness Operations
A.I.G. TECHNOLOGIES, INC.086365223manufacture(51021-302)

Revised: 7/2021
Document Id: d2a46962-1676-4a72-a5df-9a591757527d
Set id: 44a1300b-9601-4f86-9606-9f0b21ec64d0
Version: 3
Effective Time: 20210712
 
Sircle Laboratories, LLC