Label: BARE 40 PLUS SA- urea gel

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

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Drug Label Information

Updated February 15, 2021

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  • PRINCIPAL DISPLAY PANEL

    Label

    ACTIVE INGREDIENTS:

    UREA 40%, SALICYLIC ACID 2%, TEA TREE OIL, ALOE VERA

    SOOTHES ROUGH & DRY SKIN

    HEALS CORNS & CALLOUSES

    SOOTHES ROUGH & DRY SKIN

    FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES.

    KEEP OUT OF REACH OF CHILDREN. STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS.

    KEEP LID FIRMLY CLOSED. STORE IN COOL DRY PLACE.

    KEEP OUT OF REACH OF CHILDREN.

    APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR AS NEEDED.USE CONTINUOUSLY FOR 2-3 WEEKS FOR OPTIMAL RESULTS.

    CARBOMER, XANTHAN GUM, MINERAL OIL, PROPYLENE GLYCOL,EMULSIFIERS, TRIETHANOLAMINE

    KEEP LID FIRMLY CLOSED. STORE IN COOL DRY PLACE.

    ENHANCED WITH TEA TREE OIL & ALOE VERA

    APPLY TO AFFECTED AREA AT LEAST TWICE DAILY OR AS NEEDED.USE CONTINUOUSLY FOR 2-3 WEEKS FOR OPTIMAL RESULTS.

    FOR EXTERNAL USE ONLY. AVOID CONTACT TO EYES. STOP USE AND CONSULT DOCTOR IF CONDITION WORSENS OR CLEARS UP AND REOCCURS.

  • INGREDIENTS AND APPEARANCE
    BARE 40 PLUS SA 
    urea gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81376-222
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA40 g  in 113 g
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID6.5 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    WATER (UNII: 059QF0KO0R)  
    TRIDECETH-10 (UNII: G624N6MSBA)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    Colorwhite (Opaque White) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81376-222-01113 g in 1 JAR; Type 0: Not a Combination Product09/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/20/2019
    Labeler - SSG Ventures Inc (047626115)
    Establishment
    NameAddressID/FEIBusiness Operations
    SSG Ventures Inc047626115manufacture(81376-222)
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