Label: ROUND AROUND ESSENTIAL BOOSTING HYDRATOR- dimethicone liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 71596-064-01, 71596-064-02 - Packager: CJ OliveNetworks Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 August 19, 2019
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients:
CHAMAECYPARIS OBTUSA WATER, METHYLPROPANEDIOL, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, GLYCERIN, HYDROGENATED POLY(C6-14 OLEFIN), NEOPENTYL GLYCOL DIHEPTANOATE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, WATER, 1,2-HEXANEDIOL, BETAINE, PENTYLENE GLYCOL, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, SQUALANE, GLYCERYL STEARATE, PEG-100 STEARATE, PHENOXYETHANOL, CARBOMER, POLYSORBATE 20, TROMETHAMINE, ETHYLHEXYLGLYCERIN, SODIUM STEAROYL GLUTAMATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, HYDROGENATED POLYISOBUTENE, FRAGRANCE, POLYSORBATE 60, ALCOHOL, ARGANIA SPINOSA KERNEL OIL, HYDROGENATED LECITHIN, ISONONYL ISONONANOATE, POLYGLYCERYL-10 STEARATE, DISODIUM EDTA, BUTYROSPERMUM PARKII (SHEA) BUTTER, CETEARYL ALCOHOL, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, STEARIC ACID, SORBITAN ISOSTEARATE, CAMELLIA JAPONICA SEED OIL, CAMELLIA SINENSIS SEED OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, MACADAMIA INTEGRIFOLIA SEED OIL, OLEA EUROPAEA (OLIVE) FRUIT OIL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, SODIUM HYALURONATE, OCTYLDODECANOL, AMARANTHUS CAUDATUS SEED EXTRACT, ULMUS DAVIDIANA ROOT EXTRACT, CENTELLA ASIATICA EXTRACT, FICUS CARICA (FIG) FRUIT EXTRACT, INULIN LAURYL CARBAMATE, MONASCUS EXTRACT, CNIDIUM OFFICINALE ROOT EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, PAEONIA LACTIFLORA ROOT EXTRACT, PUERARIA THUNBERGIANA ROOT EXTRACT, ECHIUM PLANTAGINEUM SEED OIL, PORTULACA OLERACEA EXTRACT, SOLUBLE COLLAGEN, XANTHAN GUM, CERAMIDE NP, DISODIUM STEAROYL GLUTAMATE, ALOE BARBADENSIS LEAF JUICE, TOCOPHEROL, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES - PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- Uses
- Directions
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROUND AROUND ESSENTIAL BOOSTING HYDRATOR
dimethicone liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71596-064 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone 2.49 g in 120 mL Inactive Ingredients Ingredient Name Strength CHAMAECYPARIS OBTUSA WOOD OIL (UNII: P2OMP71Y62) METHYLPROPANEDIOL (UNII: N8F53B3R4R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71596-064-02 1 in 1 CARTON 07/01/2019 1 NDC:71596-064-01 120 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 07/01/2019 Labeler - CJ OliveNetworks Co., Ltd. (688271303) Registrant - CJ OliveNetworks Co., Ltd. (688271303) Establishment Name Address ID/FEI Business Operations Kolmar Korea Co., Ltd. 689512611 manufacture(71596-064)
