OXYGENETIX OXYGENATING FOUNDATION ACNE CONTROL (SALICYLIC ACID) LOTION [COLONIAL DAMES CO LTD]

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OXYGENETIX OXYGENATING FOUNDATION ACNE CONTROL (SALICYLIC ACID) LOTION [COLONIAL DAMES CO LTD]
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NDC 10258-101-11
Set ID f1126359-649b-4f68-ae46-9a78975dadac
Category HUMAN OTC DRUG LABEL
Packager COLONIAL DAMES CO LTD
Generic Name
Product Class
Product Number
Application Number PART333D
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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT

    SALICYLIC ACID 2%

  • PURPOSE

    PURPOSE
    ACNE TREATMENT

  • INDICATIONS & USAGE

    USES

    • FOR THE TREATMENT OF ACNE.
  • WARNINGS

    WARNINGS
    FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. DISCONTINUE USE IF SIGNS OF IRRITATION OR RASH APPEAR.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • DIRECTIONS

    APPLY WITH CLEAN SPONGE OR FINGERTIPS. BLEND UNTIL EVEN. FINISH BY APPLYING MORE IF NEEDED, FOR MAXIMUM COVERAGE.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS
    ALOE BARBADENSIS GEL, ISODODECANE, TITANIUM DIOXIDE, METHICONE, POLYGLYCERYL-4 ISOSTEARATE, CETYL DIMETHICONE COPOLYOL, HEXYL LAURATE, CYCLOPENTASILOXANE, PEG/PPG-20/15 DIMETHICONE, SACCHAROMYCES CEREVISIAE, PEG-8, DIOCTYLDODECYL DODECANEDIOATE, IRON OXIDES, VITIS VINIFERA (GRAPE) SEED EXTRACT, GLYCERIN, O-CYMEN-5-OL, SILICA, CYCLOMETHICONE, DISTEARDIMONIUM HECTORITE, PROPYLENE CARBONATE, MARIS SAL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER.

  • PRINCIPAL DISPLAY PANEL

    Label_Front_Acne ControlLabel_Back_Acne Control

  • INGREDIENTS AND APPEARANCE
    OXYGENETIX OXYGENATING FOUNDATION  ACNE CONTROL
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10258-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISODODECANE (UNII: A8289P68Y2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PEG/PPG-20/15 DIMETHICONE (UNII: 06R6X77P9C)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    DIOCTYLDODECYL DODECANEDIOATE (UNII: 7QDB5EE79Y)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    O-CYMEN-5-OL (UNII: H41B6Q1I9L)  
    SILICON (UNII: Z4152N8IUI)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SEA SALT (UNII: 87GE52P74G)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10258-101-1115 mL in 1 BOTTLE; Type 0: Not a Combination Product12/21/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/21/2014
    Labeler - COLONIAL DAMES CO LTD (008490385)
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