Label: READYBATH TPC TOTAL PERINEAL CARE- dimethicone cloth
READYBATH TPC- dimethicone cloth
READYCLEANSE CLEANSING WIPES- dimethicone cloth
ALOETOUCH PREMIUM SPUNLACE CLEANSING CLOTHS- dimethicone cloth
ALOETOUCH PREMIUM SPUNLACE- dimethicone cloth
READYFLUSH XLARGE PERSONAL CLEANSING CLOTHS- dimethicone cloth

  • NDC Code(s): 53329-060-09, 53329-061-09, 53329-062-09, 53329-063-09, view more
    53329-065-57, 53329-066-58, 53329-066-62
  • Packager: Medline Industries, Inc.
  • 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 June 2, 2023

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  • Active ingredient

    Dimethicone 3.2%

  • 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

    • avoid direct contact with 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 consult 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)

  • ACTIVE Package Label 53329-060

    Label RD12MSC

  • DEACTIVATED Package Label 53329-061

    Label 602283

  • DEACTIVATED Package Label 53329-062

    Label 602813TL

  • DEACTIVATED Package Label 53329-063

    Label 39503TL

  • DEACTIVATED Package Label 53329-065

    Label RD05MSC

  • DEACTIVATED Package Label 53329-066

    Label 066

  • INGREDIENTS AND APPEARANCE
    READYBATH TPC  TOTAL PERINEAL CARE
    dimethicone cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.544 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-060-093 in 1 PACKAGE; Type 0: Not a Combination Product01/01/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01601/01/2007
    READYBATH TPC 
    dimethicone cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-061
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.608 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-061-098 in 1 PACKAGE; Type 0: Not a Combination Product01/01/200707/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/200707/01/2014
    READYCLEANSE  CLEANSING WIPES
    dimethicone cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-062
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.294 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-062-0924 in 1 PACKAGE; Type 0: Not a Combination Product01/01/200707/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/200707/01/2014
    ALOETOUCH  PREMIUM SPUNLACE CLEANSING CLOTHS
    dimethicone cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-063
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.294 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-063-0948 in 1 PACKAGE; Type 0: Not a Combination Product01/01/200707/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/200707/01/2014
    ALOETOUCH  PREMIUM SPUNLACE
    dimethicone cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-065
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.352 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-065-5760 in 1 PACKAGE; Type 0: Not a Combination Product01/01/200707/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/200707/01/2014
    READYFLUSH XLARGE  PERSONAL CLEANSING CLOTHS
    dimethicone cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-066
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.294 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-066-5824 in 1 PACKAGE; Type 0: Not a Combination Product01/01/200707/01/2014
    2NDC:53329-066-6260 in 1 PACKAGE; Type 0: Not a Combination Product01/01/200707/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/01/200707/01/2014
    Labeler - Medline Industries, Inc. (025460908)
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