Label: TOUCHLESS CARE ZINC OXIDE PROTECTANT 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 April 13, 2016

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  • Active Ingredients

    Zinc Oxide 25%

    Dimethicone 20%

  • Purpose

    Skin Protectant

    Skin Protectant

  • Uses

    • Helps treat and prevent diaper rash associated with incontinence - associated dermatitis.
    • Protects minor skin irritation due to excess moisture, urine or stool.
    • Helps seal out wetness.
  • Warnings

    Do not use on deep puncture wounds, serious burns, animal bites, or broken skin. For external use only. When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

  • Stop use and ask a doctor if

    condition worsens or symptoms last more than 7 days or clear up and occur again within a few days.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a poison control center immediately.

  • 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.
  • Other Information

    Store at 59º F - 87º F (15º C - 30º C)

  • Inactive Ingredients

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

  • Package Label

    samples

  • Sample card

    Sample card

  • INGREDIENTS AND APPEARANCE
    TOUCHLESS CARE ZINC OXIDE PROTECTANT 
    touchless care zinc oxide protectant spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69502-504
    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
    LANOLIN (UNII: 7EV65EAW6H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    CORN OIL (UNII: 8470G57WFM)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69502-504-033 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/14/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/14/2016
    Labeler - Crawford Healthcare, Inc. (042813710)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Creations, Inc.079375497manufacture(69502-504) , pack(69502-504) , label(69502-504)
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