Label: ALOETOUCH PROTECT FRAGRANCE FREE- dimethicone cloth

  • NDC Code(s): 53329-059-02, 53329-059-58, 53329-059-62, 53329-059-76, view more
    53329-059-91
  • Packager: Medline Industries, LP
  • 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 December 14, 2022

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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 waste receptacle
  • Other information

    • Protect from freezing, avoid excessive heat
    • Keep lid tightly sealed
    • Not made with natural rubber latex
    • Do not flush
    • Cloth: made of Rayon/Polyester
  • 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 for: Medline Industries, Inc.

    Three Lakes Drive, Northfield IL 60093 USA

    Made in USA with Domestic and Foreign Materials

    www.medline.com

    1-800-MEDLINE

    REF: MSC095223

    V3 RH21MSC

  • Package Label

    Label

  • INGREDIENTS AND APPEARANCE
    ALOETOUCH PROTECT  FRAGRANCE FREE
    dimethicone cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-059
    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:53329-059-023 in 1 PACKAGE07/01/2014
    117 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:53329-059-768 in 1 PACKAGE07/01/2014
    219 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    3NDC:53329-059-5824 in 1 PACKAGE07/01/2014
    39.2 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    4NDC:53329-059-9148 in 1 PACKAGE07/01/201411/01/2022
    49.2 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    5NDC:53329-059-6260 in 1 PACKAGE08/01/201210/31/2016
    511 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)
    Registrant - Medline Industries, LP (025460908)
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