Label: CVS SIMPLE CARE PROTECTIVE RASH- dimethicone spray

  • Category: HUMAN OTC DRUG LABEL

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 May 5, 2014

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  • Active ingredient

    Dimethicone, 1.0%

  • Purpose

    Skin protectant

  • Uses

    •
    Helps prevent and temporarily protects chafed, chapped and cracked skin.
  • Warnings

    For external use only.

  • Flammable:

    Do not use near flame or sparks or while smoking. Contents under pressure. Do not puncture or incinerate or store at temperatures above 120°F.

  • When using this product

    •
    do not get into eyes
  • Stop use and ask a doctor if

    •
    condition worsens
    •
    symptoms last more than 7 days or clear up and occur again within a few days
  • Do not use on

    •
    deep or puncture wounds
    •
    serious burns
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Use only as directed.

    Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

  • Directions

    •
    Remove wet and soiled clothing, cleanse affected area, and dry area completely. Holding can 8 inches from desired area, with a sweeping motion, apply as directed. Spray on targeted area, let air dry for 30 seconds prior to dressing. Can be used day or night as often as needed.
  • Other Information

    •
    store at 20° to 25°C (68° to 77°F)
  • Inactive Ingredients

    caprylic/capric triglyceride, propane, butane, isobutene, mineral oil, butyrospermum parkii (shea butter), tocopheryl acetate (vitamin E), chamomilla recutita (matricaria) flower oil, bisabolol.

  • Package/Label Principal Display Panel - Carton Label

    CVS pharmacy™
    continuous spray lotion rash protection

    Provides a protective moisture barrier

    Enriched with chamomile & vitamin E
    Continuous spray for easy application
    Fragrance free & alcohol free

    Skin Protectant

    6.78 FL OZ (200 mL)

    CVS/pharmacy™ Continuous Spray Lotion Rash Protection provides a protective moisture barrier enriched with chamomile and vitamin E.

    Distributed by:
    CVS Pharmacy, Inc.
    One CVS Drive
    Woonsocket, RI 02895
    © 2014 CVS/pharmacy
    CVS.com®
    1-800-SHOP CVS

    Made in Israel V-31477
    ID14D 17 E1

    CVS® Quality
    Money Back Guarantee

    Container Label
     
    Container Label
  • INGREDIENTS AND APPEARANCE
    CVS SIMPLE CARE PROTECTIVE RASH 
    dimethicone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-142
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPANE (UNII: T75W9911L6)  
    BUTANE (UNII: 6LV4FOR43R)  
    ISOBUTANE (UNII: BXR49TP611)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-142-12200 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2014
    Labeler - CVS Pharmacy (062312574)
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