Label: RASH RELIEF ANTIBACTERIAL- bacitracin dimethicone zinc oxide 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 November 16, 2011

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  • Active Ingredients

    Bacitracin               500 units/g

    Dimethicone             20%       

    Petrolatum               25%


  • Purpose

    Antibacterial / Skin Protectant

  • Warnings

    - Do not use over deep or puncture wounds, infections, or lacerations.  Do not apply over large areas of the body.

    - When using this product do not get into eyes.  If contact occurs, rinse eyes thoroughly with water.  For external use only. 

    - Stop use and ask a doctor if condition worsens or does not improve in 7 days..

  • Directions

    - Cleanse the skin area, and allow to dry. 

    - Shake bottle well before use.

    - Spray 4-6 inches from skin. No rub-in is required.

    - Apply liberally as often as necessary to soothe and protect irritated skin.


  • Inactive Ingredients

    Cyclomethicone, Hexamethyldisiloxane, Lanolin, Light Mineral Oil, Microcrystalline Wax, Vitamin A Palmitate, Vitamin D3, Water, White Petrolatum

  • KEEP OUT OF REACH OF CHILDREN


    - Keep out of reach of children.  If swallowed, get medical help or contact a local poison control center immediately.

  • INDICATIONS & USAGE


    Uses: First aid to help prevent infection in minor cuts, scrapes, and burns.  Treats and prevents minor skin irritation: itching, diaper rash, feeding tube sites, cuts, and minor burns.

  • PRINCIPAL DISPLAY PANEL

    RRABSPRAYEnter section text here

  • INGREDIENTS AND APPEARANCE
    RASH RELIEF ANTIBACTERIAL 
    bacitracin dimethicone zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15071-672
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacitracin (UNII: 58H6RWO52I) (Bacitracin - UNII:58H6RWO52I) Bacitracin500 [iU]  in 1 g
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone20 g  in 100 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Cyclomethicone (UNII: NMQ347994Z)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Lanolin (UNII: 7EV65EAW6H)  
    Microcrystalline Wax (UNII: XOF597Q3KY)  
    Hexamethyldisiloxane (UNII: D7M4659BPU)  
    Water (UNII: 059QF0KO0R)  
    Cholecalciferol (UNII: 1C6V77QF41)  
    Vitamin a palmitate (UNII: 1D1K0N0VVC)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15071-672-1128 g in 1 BOTTLE
    2NDC:15071-672-2244 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B06/14/2006
    Labeler - Touchless Care Concepts LLC (083459334)
    Registrant - Touchless Care Concepts LLC (083459334)
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