Label: BIO-SORB- capsaicin cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51021-302-08 - Packager: Sircle Laboratories, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 12, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
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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.
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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
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 237 ml Bottle Label
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INGREDIENTS AND APPEARANCE
BIO-SORB
capsaicin creamProduct 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) 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 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. 086365223 manufacture(51021-302)
