Label: RASH RELIEF- zinc oxide dimethicone spray

  • 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 October 18, 2011

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  • Active Ingredients

    Dimethicone             20%       

    Zinc Oxide               25%


  • Purpose

    Skin Protectant


    Uses: Treats and prevents minor skin irritation - itching - diaper rash - feeding tubes sites, or lacerations.

  • Warnings

    - Do not use over deep or puncture wounds, infections, or lacerations.  For external use only.

    - When using this product do not get into eyes.  If contact occurs, rinse eyes throughout with water.

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

  • Directions

    - Cleanse 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- each diaper change with incontinence care- to soothe and protect irritated skin.

  • Inactive Ingredients

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

  • INDICATIONS & USAGE


    Uses: Treats and prevents minor skin irritation - itching - diaper rash - feeding tubes sites, or lacerations.
  • 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.

  • PRINCIPAL DISPLAY PANEL


    RR25

  • INGREDIENTS AND APPEARANCE
    RASH RELIEF 
    zinc oxide dimethicone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15071-604
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide25 g  in 100 g
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Mineral Oil (UNII: T5L8T28FGP)  
    Cyclomethicone (UNII: NMQ347994Z)  
    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:15071-604-1156 g in 1 BOTTLE, SPRAY
    2NDC:15071-604-22128 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/21/2005
    Labeler - Touchless Care Concepts LLC (083459334)
    Registrant - Touchless Care Concepts LLC (083459334)
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