Label: 2% SALICYLIC ACID BODY WASH FOR ACNE PRONE SKIN- glycerin, sodium pca, salicylic acid, kaolin clay, vitamin b5, vitamin e, rosa canina fruit oil liquid

  • 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 April 11, 2023

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  • SPL UNCLASSIFIED SECTION

    This Body wash is expertly formulated to specifically target body acne concerns. Salicylic Acid, Kaolin Clay, Rosehip Oil, and Glycerin present in this extraordinary body wash will eliminate acne while keeping your skin deeply hydrated and nourished.

  • Drug Facts

    Active ingdredient                                                                          Purpose

    Glycerin 5.0%.....................................................................Adds Hydration

    Sodium PCA 2.00% ....................................................Adds Moisturisation

    Salicylic acid 2.0% ...................................................................Treats Acne

    Kaolin clay 2.0% ......................................................................Absorbs Oil

    Vitamin B5 1.00% ........................................................Reduces Blemishes

    Vitamin E 0.50% .....................................................Reduces Inflammation

    Rosa Canina Fruit Oil 0.10% ............................Hydrates Dry & Itchy Skin

  • PURPOSE

  • Use

    For treatment of acne-prone skin

  • 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 and massage gently on your dampened body. Rinse thoroughly with warm water.

  • 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 orcall 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

  • DOSAGE & ADMINISTRATION

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    2% Salicylic Acid BODY WASH FOR ACNE PRONE SKIN - NDC 83325-001-01 - 472 mL Bottle Label

    image description

  • INGREDIENTS AND APPEARANCE
    2% SALICYLIC ACID BODY WASH FOR ACNE PRONE SKIN 
    glycerin, sodium pca, salicylic acid, kaolin clay, vitamin b5, vitamin e, rosa canina fruit oil liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83325-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN50 mg  in 472 mL
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) (PYRROLIDONE CARBOXYLIC ACID - UNII:6VT1YZM21H) SODIUM PYRROLIDONE CARBOXYLATE20 mg  in 472 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 472 mL
    KAOLIN (UNII: 24H4NWX5CO) (KAOLIN - UNII:24H4NWX5CO) KAOLIN20 mg  in 472 mL
    PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID10 mg  in 472 mL
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL5 mg  in 472 mL
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ) (ROSA CANINA FRUIT OIL - UNII:CR7307M3QZ) ROSA CANINA FRUIT OIL1 mg  in 472 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    LUVISET 360 (UNII: 05BG6GY6YK)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83325-001-01472 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 LIMITED854270676label(83325-001) , manufacture(83325-001) , pack(83325-001)
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