Label: SIERO LABBRA SATIN BRITISH ORANGE- dimethicone gel
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Contains inactivated NDC Code(s)
NDC Code(s): 71472-150-01, 71472-150-02 - Packager: JNG KOREA CO.,LTD.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated June 29, 2017
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients: HYDROGENATED POLYISOBUTENE, SILICA, KAOLIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, DIISOSTEARYL MALATE, DIMETHICONE CROSSPOLYMER, BIS-DIGLYCERYL POLYACYLADIPATE-2, POLYETHYLENE, TITANIUM DIOXIDE, RED 6 (CI 15850), YELLOW 6 LAKE(CI 15985), CALCIUM ALUMINUM BOROSILICATE, MICA, PHENOXYETHANOL, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, TOCOPHERYL ACETATE, FRAGRANCE, RED 7 LAKE(CI 15850:1), IRON OXIDES(CI 77499), TOCOPHEROL, TIN OXIDE, ROSA CANINA FRUIT OIL, EUCALYPTUS GLOBULUS LEAF OIL, GLYCERIN, WATER, RHODODENDRON FERRUGINEUM EXTRACT
- PURPOSE
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WARNINGS
Warnings: - There may by cracks or cakiness due to the nature of product formulations, but there is no problem with the product. Please do not worry about it. - 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
- Uses
- Directions
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SIERO LABBRA SATIN BRITISH ORANGE
dimethicone gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71472-150 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 2.1 g in 7.5 mL Inactive Ingredients Ingredient Name Strength KAOLIN (UNII: 24H4NWX5CO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71472-150-02 1 in 1 CARTON 06/01/2017 1 NDC:71472-150-01 7.5 mL in 1 CONTAINER; Type 0: Not a Combination Product 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 Business Operations JNG KOREA CO.,LTD. 557796103 relabel(71472-150) Establishment Name Address ID/FEI Business Operations Kolmar Korea Co., Ltd. 689847167 manufacture(71472-150)