OTC Medication Information: Ultra V RENEWDERM PLUS

ULTRA V RENEWDERM PLUS- dimethicone cream
Ultra V Co., Ltd

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.

ACTIVE INGREDIENT

Active ingredients: Dimethicone 7.63%

INACTIVE INGREDIENT

Inactive ingredients: Water, Glycerin, Cyclopentasiloxane, Butylene Glycol, Centella Asiatica Extract, Cyclohexasiloxane, Arbutin , Alcohol , PEG/PPG-19/19 Dimethicone, Beta-Glucan , Biosaccharide Gum-1 , Piper Methysticum Leaf/Root/Stem Extract, Dimethicone/Vinyl Dimethicone Crosspolymer , Glycyrrhiza Glabra (Licorice) Root Extract, Dipotassium Glycyrrhizate, Phellinus Linteus Extract , Phenoxyethanol, Methylparaben, Betaine , Acetyl Hexapeptide-8, Copper Tripeptide-1 , Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, rh-Oligopeptide-1, Sodium Metabisulfite, Glyceryl Acrylate/Acrylic Acid Copolymer, Disodium EDTA, Benzophenone-9, Fragrance, Propylene Glycol, Sodium Hyaluronate

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Uses: Helps protect skin

Directions

Directions: After facial wash, apply an adequate amount on face and neck. Apply twice a day on normal skin, morning and night, at the last stage of skin care. Tap gently for max absorption.

QUESTIONS

Questions:

TEL,+82-539-3450

www.ultravcosmetic.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

ULTRA V RENEWDERM PLUS
dimethicone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71975-010
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dimethicone (DIMETHICONE) Dimethicone 3.81 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
Water
Glycerin
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71975-010-02 1 TUBE in 1 CARTON contains a TUBE (71975-010-01)
1 NDC:71975-010-01 50 mL in 1 TUBE This package is contained within the CARTON (71975-010-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 01/02/2018
Labeler — Ultra V Co., Ltd (689004748)
Registrant — Ultra V Co., Ltd (689004748)
Establishment
Name Address ID/FEI Operations
NEW & NEW CO.,LTD. 557821160 manufacture (71975-010)

Revised: 04/2020 Ultra V Co., Ltd

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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