Label: ATOA- rice bran extract cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 20, 2022

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  • purpose

    Topical analgesic, Moisturizing, Skin protectant,Brightening

  • Use

    Helps moistureize and relieve itching of dry skin.

    Helps strengthen the weakened skin barrier.

  • Warnings

    Do not use on damaged or broken skin.

  • Warnings

    When using this product, do not use other than directed.

  • Warnings

    Stop use and ask a doctor if irritation occurs.

  • Warnings

    For external use only

    Store at room temperature and avoid direct sunlight and high temperatures.

  • Warnings

    Keep out of reach of children.

  • Directions

    ◾Take an appropriate amount and gently spread it over.

    ◾Reapply it frequently on the itchy area.

  • active ingredient

    Rice Bran extract

    Scutellaria baicalensis root extract

    Opuntia humifusa stem extract

    Sophora flavescens root extract

    Angelica gigas root extract

    Panax ginseng root extract

  • Inactive Ingredients

    Purified water, Rice bran oil, Camellia Japonica Seed Oil, Sunflower seed oil, Glycerin, Butylene glycol, Simmondsia chinensis seed oil, Olive oil, Aloe baradensis leaf extract, Glyceryl caprylate, Centella Asiatica extract, Astragalus membranaceus root extract, Caprylyl glycol, Lavender oil, Sorbitan olivate, Xanthan gum, Ethylhexylglycerin, 1,2-Hexanediol, Disodium EDTA

  • Other information

    Best before: 3 months after opening

    Expiration date: indicated separately

    Store at room temperature.

  • Question? Comments?

    070-7576-2728

    https://prosafebio.com

  • ATOA

    LABEL

    81745-301

    ATOA

  • INGREDIENTS AND APPEARANCE
    ATOA 
    rice bran extract cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81745-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RICE BRAN (UNII: R60QEP13IC) (RICE BRAN - UNII:R60QEP13IC) RICE BRAN4 g  in 100 mL
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) (SOPHORA FLAVESCENS ROOT - UNII:IYR6K8KQ5K) SOPHORA FLAVESCENS ROOT1 g  in 100 mL
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) (SCUTELLARIA BAICALENSIS ROOT - UNII:7J95K7ID2S) SCUTELLARIA BAICALENSIS ROOT1 g  in 100 mL
    OPUNTIA HUMIFUSA WHOLE (UNII: 6E9O5V4SS5) (OPUNTIA HUMIFUSA WHOLE - UNII:6E9O5V4SS5) OPUNTIA HUMIFUSA WHOLE1 g  in 100 mL
    ANGELICA GIGAS ROOT (UNII: 32766B2FHX) (ANGELICA GIGAS ROOT - UNII:32766B2FHX) ANGELICA GIGAS ROOT1 g  in 100 mL
    ASIAN GINSENG (UNII: CUQ3A77YXI) (ASIAN GINSENG - UNII:CUQ3A77YXI) ASIAN GINSENG0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASTRAGALUS PROPINQUUS ROOT POLYSACCHARIDES (UNII: 71WW2LNL50)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    GLYCERYL CAPRATE (UNII: 197M6VFC1W)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    WATER (UNII: 059QF0KO0R)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81745-301-01300 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/07/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/07/2022
    Labeler - PROSAFEBIO (695501710)
    Registrant - PROSAFEBIO (695501710)
    Establishment
    NameAddressID/FEIBusiness Operations
    PROSAFEBIO695501710manufacture(81745-301)
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