OTC Medication Information: SIERO VANISH OI L POWDE R PACT

SIERO VANISH OI L POWDE R PACT- dimethicone powder
JNG KOREA 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 1.05%

INACTIVE INGREDIENT

Inactive ingredients: TALC, POLYMETHYL METHACRYLATE,HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, POLYETHYLENE, SILICA, 1,2-HEXANEDIOL, TRIETHOXYCAPRYLYLSILANE, GLYCERYL CAPRYLATE, WATER, BUTYLENE GLYCOL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF EXTRACT, PHENOXYETHANOL, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER/LEAF/STEM EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT, ETHYLHEXYLGLYCERIN

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: — Keep away from direct sunlight and high temperature. — 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

Uses

Uses: Light powder pact without being cakey, even with several applications Ultra-light touch powder is adheres tightly to cover skin flaws, such as pores and sebum, and provide a fresh finish without cakiness, even with several applications. Cares for sweat and sebum, and the reduced oil content makes it possible to use every day with the light feeling of a powder.

Directions

Directions: Take a moderate amount using a puff and spread it over the entire face with a light dab.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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SIERO VANISH OI L POWDE R PACT
dimethicone powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71472-260
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 1.05 g in 10 g
Inactive Ingredients
Ingredient Name Strength
TALC
1,2-HEXANEDIOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71472-260-02 1 CONTAINER in 1 CARTON contains a CONTAINER (71472-260-01)
1 NDC:71472-260-01 10 g in 1 CONTAINER This package is contained within the CARTON (71472-260-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 06/01/2017
Labeler — JNG KOREA CO.,LTD. (557796103)
Registrant — JNG KOREA CO.,LTD. (557796103)
Establishment
Name Address ID/FEI Operations
JNG KOREA CO.,LTD. 557796103 relabel (71472-260)
Establishment
Name Address ID/FEI Operations
Kolmar Korea Co., Ltd. 689847167 manufacture (71472-260)

Revised: 06/2017 JNG KOREA 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.

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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