BIO-SORB- capsaicin cream

Bio-Sorb by

Drug Labeling and Warnings

Bio-Sorb by is a Otc medication manufactured, distributed, or labeled by Sircle Laboratories, LLC, A.I.G. TECHNOLOGIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• This is not a face cream. Do not apply to the face.
• Do not use if allergic to chili peppers or if past allergic reaction to capsaicin.
• Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin.
• Do not bandage tightly.
• Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise. Warm water, perspiration or open pores can intensify the impact of this product and burning sensation.
• Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burns.

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

• Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock
• Before using on children under 18 years of age consult a physician.
• Apply sparingly to affected area not more than 4 times daily. However, for First use, apply to small area to test for sensitivity or skin reaction.
• Gently massage into the skin until fully absorbed.
• Wash hands with soap and water thoroughly after each application to avoid spreading to the eyes or other sensitive mucous membranes.

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)

INGREDIENTS AND APPEARANCE

BIO-SORB 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51021-302
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.025 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
GLYCERIN (UNII: PDC6A3C0OX)
TROLAMINE (UNII: 9O3K93S3TK)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51021-302-08	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/20/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/20/2018

Labeler - Sircle Laboratories, LLC (962175621)

Establishment
Name	Address	ID/FEI	Business Operations
A.I.G. TECHNOLOGIES, INC.		171837367	manufacture(51021-302)