Label: ROVECTIN ANTI IRRITANT BARRIER REPAIR ULTRA- dimethicone cream

  • 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 4, 2012

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT: DIMETHICONE 1.80%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:
    WATER, CYCLOPENTASILOXANE, BUTYROSPERMUM PARKII (SHEA BUTTER), HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, NIACINAMIDE, GLYCERIN, SQUALANE, CETEARYL METHICONE, PHENOXYETHANOL, RICINUS COMMUNIS (CASTOR) SEED OIL, PERSEA GRATISSIMA (AVOCADO) OIL, OLIVE GLYCERIDES, HEXYLDECANOL, POLYSORBATE 60, LINOLEIC ACID, GLYCINE SOJA (SOYBEAN) STEROLS, PHOSPHOLIPIDS, ALOE BARBADENSIS LEAF JUICE, HYDROXYETHYLCELLULOSE, ETHYLHEXYLGLYCERIN, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, SODIUM PHYTATE, TOCOPHEROL, CERAMIDE 3, SODIUM HYDROXIDE, HAEMATOCOCCUS PLUVIALIS EXTRACT

  • PURPOSE

    PURPOSE: SKIN PROTECTANT

  • WARNINGS

    WARNINGS:
    FOR EXTERNAL USE ONLY.
    AVOID CONTACT WITH EYES.
    STOP USE AND ASK A DOCTOR IF CONDITION WORNSENS.
    DO NOT USE ON DEEP OR PUNCTURE WOUNDS.
    KEEP OUT OF THE REACH OF CHILDREN.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS AND USAGE

    Directions:
    Apply to face, neck, hands, feet and body.
    Use as often as necessary.

  • DOSAGE AND ADMINISTRATION

    Directions:
    Apply to face, neck, hands, feet and body.
    Use as often as necessary.

  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ROVECTIN  ANTI IRRITANT BARRIER REPAIR ULTRA
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52970-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone1.8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Shea Butter (UNII: K49155WL9Y)  
    Niacinamide (UNII: 25X51I8RD4)  
    Glycerin (UNII: PDC6A3C0OX)  
    Squalane (UNII: GW89575KF9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52970-010-01100 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2012
    Labeler - SECOND FORMULA INC. (557819411)
    Registrant - SECOND FORMULA INC. (557819411)
    Establishment
    NameAddressID/FEIBusiness Operations
    SECOND FORMULA INC.557819411manufacture(52970-010)
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