Label: BEAUTY FOX ATOCLINIC- dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70129-001-01, 70129-001-02 - Packager: Beauty Fox 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 September 30, 2015
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Centella Asiatica Leaf Water, Purified Water, Water, Glycerin, Centella Asiatica Extract, Butylene Glycol , Butylene Glycol Dicaprylate/Dicaprate, Sunflower Seed Oil, Caprylic/Capric Triglyceride, Dipropylene Glycol, Squalane, Sorbitan Stearate, Beeswax, Cetyl Alcohol, Stearyl Alcohol, Cyclopentasiloxane, Betaine, Macadamia Seed Oil, Cyclohexasiloxane, Shea Butter, Cetearyl Olivate, Polysorbate 60, Caprylyl Glycol, Sorbitan Olivate, Polysorbate 80, Isohexadecane, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Carbomer, Arginine, Allantoin, Caprylhydroxamic Acid, Tocopheryl Acetate, Tremella Fuciformis (Mushroom) Extract, Olive Oil, Asiaticoside, Avocado Oil, Punica Granatum Seed Oil, Hippophae Rhamnoides Fruit Extract, Β-Glucan, Adansonia Digitata Seed Oil, Portulaca Oleracea Extract, Dipotassium Glycyrrhizate, Witch Hazel Water, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Orange Oil, Citrus Paradisi (Grapefruit) Peel Oil, Avena Sativa (Oat) Kernel Extract, Rosemary Leaf Oil, Citrus Lemon Peel Oil, Triticum Vulgare (Wheat) Sprout Extract, Brassica Napus Sprout Extract, Brassica Oleracea Italica (Broccoli) Sprout Extract, Phaseolus Radiatus Sprout Extract, Lavender Oil, Ceramide 3, Madecassoside, Medicago Sativa (Alfalfa) Sprout Extract, Eucalyptus Globulus Leaf Oil, Lepidium Sativum Sprout Extract, Glycine Soja (Soybean) Sprout Extract, Carthamus Tinctorius (Safflower) Sprout Extract, Cedrus Atlantica Bark Oil, Pelargonium Graveolens Flower Oil, Trifolium Repens Sprout Extract, Eugenia Caryophylus (Clove) Bud Extract, Angelica Gigas Sprout Extract, Poltgonum Fagopyrum (Buckwheat) Sporout Extract, Thymus Vulgaris (Thyme) Extract, Buddleja Davidii Extract, 1,2-Hexanediol, Michelia Alba Flower Oil, Styrax Benzoin Resin Extract, Chamomilla Recutita (Matricaria) Flower Oil, Rose Flower Oil, Orange Flower Oil
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BEAUTY FOX ATOCLINIC
dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70129-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 1.6 g in 160 g Inactive Ingredients Ingredient Name Strength CENTELLA ASIATICA LEAF (UNII: 6810070TYD) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CENTELLA ASIATICA (UNII: 7M867G6T1U) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) SUNFLOWER OIL (UNII: 3W1JG795YI) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIPROPYLENE GLYCOL (UNII: E107L85C40) SQUALANE (UNII: GW89575KF9) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) YELLOW WAX (UNII: 2ZA36H0S2V) CETYL ALCOHOL (UNII: 936JST6JCN) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BETAINE (UNII: 3SCV180C9W) MACADAMIA OIL (UNII: 515610SU8C) CYCLOMETHICONE 6 (UNII: XHK3U310BA) SHEA BUTTER (UNII: K49155WL9Y) CETEARYL OLIVATE (UNII: 58B69Q84JO) POLYSORBATE 60 (UNII: CAL22UVI4M) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBITAN OLIVATE (UNII: MDL271E3GR) POLYSORBATE 80 (UNII: 6OZP39ZG8H) ISOHEXADECANE (UNII: 918X1OUF1E) SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) ARGININE (UNII: 94ZLA3W45F) ALLANTOIN (UNII: 344S277G0Z) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CULTIVATED MUSHROOM (UNII: 54C8E6W6JY) OLIVE OIL (UNII: 6UYK2W1W1E) ASIATICOSIDE (UNII: PKO39VY215) AVOCADO OIL (UNII: 6VNO72PFC1) POMEGRANATE SEED OIL (UNII: 0UI45XV0T6) HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T) CURDLAN (UNII: 6930DL209R) ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I) PURSLANE (UNII: M6S840WXG5) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) HAMAMELIS VIRGINIANA WHOLE (UNII: V663Q8TEFU) BERGAMOT OIL (UNII: 39W1PKE3JI) ORANGE OIL (UNII: AKN3KSD11B) GRAPEFRUIT OIL (UNII: YR377U58W9) OAT (UNII: Z6J799EAJK) ROSEMARY OIL (UNII: 8LGU7VM393) LEMON OIL (UNII: I9GRO824LL) WHEAT SPROUT (UNII: 3K32950CI0) BROCCOLI SPROUT (UNII: 128UH9LOAE) BEAN SPROUT (UNII: 9VZY890UEQ) LAVENDER OIL (UNII: ZBP1YXW0H8) CERAMIDE 3 (UNII: 4370DF050B) MADECASSOSIDE (UNII: CQ2F5O6YIY) ALFALFA TOP (UNII: SQI2NBY9KR) EUCALYPTUS OIL (UNII: 2R04ONI662) GARDEN CRESS SPROUT (UNII: PWQ18YNR62) SOYBEAN (UNII: L7HT8F1ZOD) SAFFLOWER (UNII: 4VBL71TY4Y) CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60) PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC) CLOVE (UNII: K48IKT5321) ANGELICA GIGAS ROOT (UNII: 32766B2FHX) BUCKWHEAT (UNII: N0Y68724R3) THYME (UNII: CW657OBU4N) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) MAGNOLIA X ALBA FLOWER OIL (UNII: 8QDN200R1S) STYRAX BENZOIN RESIN (UNII: FE663Z8IRO) CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) ROSA RUGOSA FLOWER BUD (UNII: TZ0BE8I3MW) CITRUS SINENSIS FLOWER OIL (UNII: AJ56JP5TFP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70129-001-02 1 in 1 CARTON 09/30/2015 1 NDC:70129-001-01 160 g in 1 BOTTLE; 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 09/30/2015 Labeler - Beauty Fox Co., Ltd. (688993629) Registrant - Beauty Fox Co., Ltd. (688993629) Establishment Name Address ID/FEI Business Operations Beauty Fox Co., Ltd. 688993629 manufacture(70129-001)
