RASH RELIEF (ZINC OXIDE DIMETHICONE) SPRAY [TOUCHLESS CARE CONCEPTS LLC]

RASH RELIEF (ZINC OXIDE DIMETHICONE) SPRAY [TOUCHLESS CARE CONCEPTS LLC]
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NDC 15071-604-11, 15071-604-22
Set ID 54d7250e-6aaa-4fc8-88b3-2fee58ebaf73
Category HUMAN OTC DRUG LABEL
Packager Touchless Care Concepts LLC
Generic Name
Product Class
Product Number
Application Number PART347
  • 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)