Label: 3% OAT BODY WASH FOR SENSITIVE SKIN (glycerin, oatmeal extract, sodium pca, vitamin b5, hyaluronic acid, ceramide ng, rosa canina- rosehip seed oil liquid

  • 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 April 11, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Give your body a refreshing and therapeutic touch of Oatmeal,  Glycerin and Rosehip Oil. The unique formula of this body wash gently cleanses your skin while keeping it feeling fresh, clean, and deeply nourished

  • Drug Facts

    Active Ingdredient                                                                      Purpose
    Glycerin 5.0%................................................................ Adds Hydration
    Oatmeal Extract 3.0%...............................................Reduces Sensitivity
    Sodium PCA 2.0%...................................................Adds Moisturisation
    Vitamin B5 1.0%..............................................Reduce Facial Blemishes
    Hyaluronic Acid 0.5%.................................................Reduces Wrinkles
    Ceramide NG 0.1%...................................................Reduces Sensitivity
    Rosa Canina (Rosehip) Seed oil 0.1%.............................Nourishes Skin

  • PURPOSE

  • Use

    For the treatment of sensitivity

  • Warnings

    For external use only

  • When using this product

    • Avoid contact with eyes. If contact occurs, flush thoroughly with water.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help 

  • Directions

    Squeeze a generous amount of this body wash into your hands or loofah. Apply it to the entire body, massage gently and rinse thoroughly.

  • Other Information

    Store in a cool and dry place. Keep away from direct sunlight

  • Inactive ingredients

    Demineralized water, EDTA (Ethylenediaminetetraacetic acid), Propylene Glycol, Acrylates Copolymer W400, Galsoft SCG, CAPB (Cocamidopropyl betaine), Galsoft SCI, Polyquaternium 7, D panthenol Paste, Pearl 200, EUXYL K 510, Triethanolamine.

  • Questions or Comments?

    For any queries please contact us at info@majesticpure.com or call us at +1530- 464-6426

    Distributed By & Domestic Representative Address:

    Volans Epic LLC

    Corporation Trust Centre, 1209 Orange Street, Wilmington,
    Delaware 19801, County of New Castle

    Manufactured By: 

    HCP Wellness Pvt. Ltd. 

    Plot No:08, Ozone Industrial Park,
    Bavia-Bagodara Highway, Bhayla, Ahmedabad-382220

    Mfg. LIC. NO. : GC/1348

     Product of India

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    3% OAT BODY WASH FOR SENSITIVE SKIN - NDC 83325-002-02 - 16 fl oz | 472 mL Bottle Label

    image description

  • INGREDIENTS AND APPEARANCE
    3% OAT BODY WASH FOR SENSITIVE SKIN 
    glycerin, oatmeal extract, sodium pca, vitamin b5, hyaluronic acid, ceramide ng, rosa canina (rosehip) seed oil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83325-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN50 mg  in 472 mL
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL30 mg  in 472 mL
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) (PYRROLIDONE CARBOXYLIC ACID - UNII:6VT1YZM21H) SODIUM PYRROLIDONE CARBOXYLATE20 mg  in 472 mL
    PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID10 mg  in 472 mL
    HYALURONIC ACID (UNII: S270N0TRQY) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONIC ACID5 mg  in 472 mL
    CERAMIDE NG (UNII: C04977SRJ5) (CERAMIDE NG - UNII:C04977SRJ5) CERAMIDE NG1 mg  in 472 mL
    ROSA CANINA SEED OIL (UNII: MHT97MG5P8) (ROSA CANINA SEED OIL - UNII:MHT97MG5P8) ROSA CANINA SEED OIL1 mg  in 472 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)  
    SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    LUVISET 360 (UNII: 05BG6GY6YK)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    WATER (UNII: 059QF0KO0R)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83325-002-02472 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01604/06/2023
    Labeler - Volans Epic LLC (118944905)
    Registrant - MENSA BRAND TECHNOLOGIES PRIVATE LIMITED (854380965)
    Establishment
    NameAddressID/FEIBusiness Operations
    HCP WELLNESS PRIVATE LIMITED854270676manufacture(83325-002) , label(83325-002) , pack(83325-002)