The following Structured Product Label (SPL) was submitted to the FDA by Guangdong Outeli Biotechnology Co., Ltd. for the product Celistar Microneedling Infusion (NDC 87765-001). 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 inactive ingredient, dosage & administration, warnings, otc - active ingredient, otc - keep out of reach of children, otc - purpose, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
AQUA 86.31%
ERGOTHIONEINE 0.12%
ACETYL HEXAPEPTIDE-8 AMIDE 0.08%
ACETYL TETRAPEPTIDE-11 0.06%
ACETYL TETRAPEPTIDE-9 0.04%
PALMITOYL TRIPEPTIDE-1 0.04%
PALMITOYL TETRAPEPTIDE-7 0.04%
GLYCERIN 3.5%
BUTYLENE GLYCOL 2.8%
1,2-HEXANEDIOL 0.3%
HYDROXYACETOPHENONE 0.2%
MANNITOL 0.15%
CARBOMER HOMOPOLYMER TYPE B 0.1%
L-ARGININE 0.12%
SODIUM LACTATE, L- 0.18%
Serum 5ml x 4+Mincroneedle Stamp x 4
HOW TO USE:
For best results, use every 2 weeks.Treatment time: 10-15 minutes.
1. Start with clean hands. Remove the sterile applicator from the packaging.Do not use if the sterile seal is broken.
2. Cleanse your face thoroughly with warm water and pat dry.
3. Prepare the device: Open the 5ml ampoule serum. Carefully fill the applicator's reservoir with the essence. Se-
curely screw the top back on and gently shake 2-3 times to mix.
4. Remove the protective safety cover immediately before use.
5.Application technique: Begin at the center of your face, gently stamping outward.For optimal absorption, use
a 50% overlapping pattern and repeat 2-3 times per area.
Do not use on broken, irritated, or sensitive skin.
Avoid contact with eyes. lf contact occurs,rinse
immediately with plenty of water. Discontinue
use immediately if discomfort or irritation occurs.
HYALURONATE SODIUM 3.5%
HYDROLYSED MARINE COLLAGEN(ENZYMATIC; 2000 MW) 2.5%
Keep the applicator out of reach of children.
Avoid contact with eyes.lf contact occurs, rinse immediately with plenty of water. Discontinue use immediately if discomfort or irritation occurs.
Anti-aging
Makes skin feel firmer, enhances appearance for 'a plumper,visibly improves appearance of fine lines,evens skin tone, and smoother.
Uses:
Antioxidant and skin protectant,Anti aging and wrinkle reducer, Skin moisturizer and conditioner
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Label Image (1)
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