OTC Medication Information: SIERO CHEE CHEEK CORAL

SIERO CHEE CHEEK CORAL- 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 1.70%

INACTIVE INGREDIENT

Inactive ingredients: TALC, MICA, SILICA, NYLON-12, MAGNESIUM STEARATE, OCTYLDODECYL STEAROYL STEARATE, PHENYL TRIMETHICONE, TITANIUM DIOXIDE, DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER, BORON NITRIDE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SYNTHETIC FLUORPHLOGOPITE, LAUROYL LYSINE, ETHYLENE/ACRYLIC ACID COPOLYMER, POLYMETHYL METHACRYLATE, IRON OXIDES(CI 77492), METHICONE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, PHENOXYETHANOL, ALUMINUM MYRISTATE, HYDROGENATED LECITHIN, RED 6 (CI 15850), IRON OXIDES(CI 77491), YELLOW 5 LAKE(CI 19140), SODIUM DEHYDROACETATE, IRON OXIDES(CI 77499), TIN OXIDE, SAPPHIRE POWDER, AMETHYST POWDER, PEARL POWDER

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: It is a blusher giving both cheeks natural color and bright radiance.

Directions

Directions: Use the blush brush or cushion puff to dab into the apple zone (cheeks and under eye area).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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SIERO CHEE CHEEK CORAL
dimethicone powder
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71472-240
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 0.07 g in 4.5 g
Inactive Ingredients
Ingredient Name Strength
TALC
MICA
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71472-240-02 1 CONTAINER in 1 CARTON contains a CONTAINER (71472-240-01)
1 NDC:71472-240-01 4.5 g in 1 CONTAINER This package is contained within the CARTON (71472-240-02)
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 (71472-240)
Establishment
Name Address ID/FEI Operations
Kolmar Korea Co., Ltd. 689847167 manufacture (71472-240)

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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