Label: I.C. BARRIER- benzethonium chloride and dimethicone lotion/shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 17, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients Purpose
    Benzethonium Chloride 0.2%Antibacterial
    Dimethicone 2.0%Skin Protectant
  • Uses

    Temporarily prevents, protects, and helps shield the skin from biological and chemical environments while moisturizing your skin. Kills 99.99% of Germs.

  • Warnings

    For external use only

    • When using this product, aviod contact with eyes
    • In case of eye contact, flush with water

    • Keep out of reach of children, except under adult supervision
    • If swallowed, get medical help
    • Discontinue use if skin irritation or redness develops.
  • Directions

    Apply to hands & body and rub until lotion is absorbed. Will not dry out your skin or crack your nails like Alcohol Based Sanitizers.

  • Ingredients

    DI Water, Incroquat TMS, Propylene Glycol, Sunflower Butter, Octyl Palmitate, Stearyl Alcohol, Cetyl Alcohol, Geoguard Ultra, Aloe Vera, Jojoba, Blue Agave, Blueberry, Cranberry, Pomegranate, Raspberry, Strawberry, Green Tea, Green Coffee Bean, Grape Seed, Acai Berry, Vitamins A, D, & E

  • Questions or Comments?

    Call (480) 443-9255 or visit RRlotion.com

  • PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

    R&R
    LOTION®

    I.C. BARRIER LOTION™

    "ALCOHOL FREE" SANITIZER

    8 FL. OZ. (236ML) e

    Principal Display Panel - 236 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    I.C. BARRIER 
    benzethonium chloride and dimethicone lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59555-601
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzethonium Chloride (UNII: PH41D05744) (Benzethonium - UNII:1VU15B70BP) Benzethonium Chloride2 mg  in 1 mL
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    cholecalciferol (UNII: 1C6V77QF41)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    vitamin A (UNII: 81G40H8B0T)  
    .Alpha.-Tocopherol (UNII: H4N855PNZ1)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59555-601-08237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:59555-601-0460 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    3NDC:59555-601-10946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    4NDC:59555-601-113785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A09/17/2014
    Labeler - R&R Lotion, Inc. (062979000)
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