Active Ingredients
Silicone 5%
Drmitsui Silicone Scar Remover Gel
FDA Label NDC 87096-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zhenping Renren Industry Co., Ltd. for the product Drmitsui Silicone Scar Remover (NDC 87096-003). 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 ingredients, purpose, inactive ingredients, uses, dosage & administration, directions, warnings, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
FAST RELIEF
KELOLD
ACNE PIT
STRECH MARKS
SURGICAL SCARS
HYPERTROPHIC SCARS
Inactive Ingredients
Water, Propylene Glycol, Polysorbate-80, Carbomer, Triethanolamine, Sodium Benzoate,Methylparaben, Disodium Edetate.
Uses
●Clean the scarred area with water,pat dry.
●Apply an appropriate amount of this product to the scarred area and spread evenly.
●Gently massage the scarred area for 5 to 10 minutes. Use 2 to 3 times daily or as directed by your healthcare provide
Dosage & Administration
●Clean the scarred area with water,pat dry.
●Apply an appropriate amount of this product to the scarred area and spread evenly.
●Gently massage the scarred area for 5 to 10 minutes. Use 2 to 3 times daily or as directed by your healthcare provide
Directions
For use in assisting the improvement of pathological skin scars and preventing the formation of pathological skin scars.
Not for use on wounds that have not fully healed.
Warnings
●This product is intended for patients with hypertrophic scars who meet the indications outlined in this manual.
●Consumers may use this product as directed in this manual or as prescribed by a physician.For external use only.
●Discontinue use immediately if allergic reactions occur.
●Use within one year after opening (store in a cool,dry place).
●Consult a healthcare professional before using this product concurrently with other treatments or medications. Dispose of used product as regular household waste.
●Keep out of reach of children.
Otc - Keep Out Of Reach Of Children
●Keep out of reach of children.
Other Information
Seal tightly and store in a ventilated,dry,cool,and clean place.
Questions
TELEPHONE NUMBER:1076-482-3458
TIME:09:00-18:00
Rems Administrative Information
DISTRIBUTOR
Mitsui Pharmaceutical Co., Ltd.
ADDRESS
10-24 Mega Awaza Building,3-Chome, Tensilihonmachi,Nishi-Ku, Oban City, Osaka Prefecture.
MANUFACTURED BY
Zhenping Renren Industry Co.,Ltd.
ADDRESS
No.10, Xinxing Road, Chanye Jiju District, Zhenping County,Nanyang, Henan, China
Package Label.Principal Display Panel
Principal Display Panel (Label)
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