Active Ingredient
CD73: 0.90 mg/mL
CD90: 0.90 mg/mL
CD105: 0.90 mg/mL
ICAM-1: 0.70 mg/mL
HGF: 0.50 mg/mL
Cpc Chondrocyte Preparation Suspension
FDA Label NDC 87622-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zhongke Zhongluan Biotechnology (guangdong) Co., Ltd. for the product Cpc Chondrocyte Preparation (NDC 87622-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, do not use, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Active protein-factor suspension for topical / local external use
Use
For topical / local external use; apply only to the target local area according to labeling directions.
Warnings
For topical / local external use only; do not ingest, inject, or apply to eyes, mucous membranes, or broken skin; single use only.
Ask A Doctor Before Use If You Have
active skin infection, open wounds, severe skin disease, known allergy to protein-based ingredients, or are pregnant or breastfeeding.
Ask A Doctor Or Pharmacist Before Use If You Are
using other topical medicines, anti-allergy medicines, or immune-related treatments.
Do Not Use
if the package is damaged or leaking; the storage temperature has deviated from the required range; the suspension appears abnormally turbid, discolored, or contains visible foreign matter; the product has been frozen or repeatedly frozen and thawed; or the labeled expiration date has passed.
Stop Use And Ask A Doctor If
rash, redness, swelling, itching, irritation, hypersensitivity, or any other discomfort occurs.
When Using This Product
avoid contact with eyes, mucous membranes, and broken skin; avoid vigorous shaking; do not freeze or refreeze; use immediately after opening as a single-use vial.
Keep Out Of Reach Of Children. If Swallowed,
get medical help or contact a Poison Control Center right away.
Directions
Mix gently before use. Each vial contains 3 mL; apply topically to the target skin / local area in a thin layer until absorbed; use once daily; use as a single-use vial after opening.
Other Information
Specification: 3 mL/vial; Dosage form: Suspension; Route of administration: Topical / local external use; store refrigerated at 2–8°C; do not freeze; use as a single-use vial after opening.
Inactive Ingredients
Sodium chloride, Water
Pack
3ml (789566)
* Please review the disclaimer below.
