READYFLUSH PROTECT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]

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READYFLUSH PROTECT WIPES FRAGRANCE FREE (DIMETHICONE) CLOTH [MEDLINE INDUSTRIES, INC.]
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NDC 53329-075-58
Set ID 743d21bd-c40a-4415-ad97-0d8aa99a8af7
Category HUMAN OTC DRUG LABEL
Packager Medline Industries, LP
Generic Name
Product Class
Product Number
Application Number PART347
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  • Active ingredient

    Dimethicone 3.2% w/v

  • Purpose

    Skin Protectant

  • Uses

    • temporarily protects and helps relieve chapped or cracked skin
    • protects minor skin irritation associated with perineal dermatitis
  • Warnings

    For external use only

    Do not use

    on

    • deep or puncture wounds
    • animal bites
    • serious burns

    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

    Keep out of reach of children.

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

  • Directions

    • Open package as designated
    • Remove cloths and thoroughly cleanse soiled area
    • Apply as needed
    • Dispose of cloth in toilet
  • Other information

    • Protect from freezing, avoid excessive heat
    • Keep lid tightly sealed
    • Latex Free
    • Cloth: made of 98% cellulosic fibers
  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Benzalkonium Chloride, Citric Acid, Cocamidopropyl PG-Dimonium Chloride Phosphate, Disodium EDTA, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Simethicone, Sodium Benzoate, Polysorbate 20, Water (Aqua)

  • Manufacturing Information

    Manufactured by: Medline Industries, Inc.

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA

    www.medline.com

    1-800-MEDLINE

    REF: MSC263811

    V1 RE21MSC

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    READYFLUSH PROTECT WIPES  FRAGRANCE FREE
    dimethicone cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-075
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE3.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: 5Q87K461JO)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-075-5824 in 1 PACKAGE08/01/2012
    19.2 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:53329-075-6260 in 1 PACKAGE08/01/201212/31/2016
    29.2 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/01/2012
    Labeler - Medline Industries, LP (025460908)
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