Label: TOUCHLESS CARE CLEAR 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 12, 2017

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  • Active Ingredient

    Dimethicone 20%

  • Purpose

    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 or animal bites. 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 59 oF - 87 oF (15 oC - 30 oC)

  • Inactive Ingredients

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

  • SPL Unclassified Section

    Distributed by: Crawford Healthcare, Inc. Doylestown, PA 18901

    Touchless Care is a registered trademark of Crawford Woundcare Ltd.

    © Crawford Healthcare Ltd., 2016

    www.crawfordhealthcare.com/us

    1-855-522-2211

    Made in the USA

  • Package Label

    Crawford Clear Label

  • INGREDIENTS AND APPEARANCE
    TOUCHLESS CARE CLEAR PROTECTANT 
    touchless care clear protectant spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69502-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    LANOLIN (UNII: 7EV65EAW6H)  
    HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69502-002-5746 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/09/2017
    Labeler - Crawford Healthcare, Inc. (042813710)
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