Label: REMEDY BARRIER CREAM CLOTHS- dimethicone cloth
REMEDY BARRIER CREAM CLOTHS FRAGRANCE FREE- dimethicone cloth

  • NDC Code(s): 53329-074-76, 53329-078-02, 53329-078-76, 53329-078-91
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 19, 2024

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  • Active ingredient

    Dimethicone 3.6% w/w

  • Purpose

    Skin Protectant

  • Uses

    • helps protect from minor skin irritations associated with perineal dermatitis
    • temporarily protects and helps relieve chapped or cracked skin
    • helps protect from the drying effects of wind and cold weather
  • 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

    • 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 fresh cloths and thoroughly cleanse soiled area as needed
    • Dispose of cloths in waste receptacle, do not flush in toilet
    • Single Patient Use only
  • Other information

    • Protect from freezing, avoid excessive heat
    • Keep label tightly sealed
    • Do Not Flush
    • Cloth: made of Rayon/Polyester
  • Inactive ingredients

    algae extract, allantoin, butylene glycol,
    butyrospermum parkii (shea butter) extract,
    C12-20 alkyl glucoside, C14-22 alcohols,
    camellia sinensis (green tea) extract,
    caprylic/capric triglyceride, cetyl alcohol,
    citric acid, cocoglucoside, coconut alcohol,
    7- dehydrocholesterol, disodium
    cocoamphodiacetate, ethylene brassylate,
    ethylhexylglycerin, eugenia caryophyllus
    (clove) flower extract, glycerin, glycine soja
    (soybean) oil, helianthus annuus
    (sunflower) seed oil, hydrolyzed soy
    protein, hydroxyethyl acrylate/sodium
    acryloyldimethyltaurate copolymer,
    isohexadecane, isopropyl myristate,
    lecithin, methyldihydrojasmonate,
    phenoxyethanol, phospholipids,
    polysorbate 60, tocopheryl acetate, urea,
    vanilla plantifolia fruit extract, water, yeast
    ferment extract, zea mays (corn) oil.

  • Manufacturing Information

    Manufactured for:

    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA with domestic and imported materials

    www.medline.com

    1-800-MEDLINE (633-5463)

    REF: MSC092508, MSC092507

    V2 RE22MSC, V2 RF22MSC

  • Package Label

    Label V2 RE22MSC 074

    Label V2 RF22MSC 078

  • INGREDIENTS AND APPEARANCE
    REMEDY BARRIER CREAM CLOTHS 
    dimethicone cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-078
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE3.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    CLOVE (UNII: K48IKT5321)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ALLANTOIN (UNII: 344S277G0Z)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    COCONUT ALCOHOL (UNII: 13F4MW8Y9K)  
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
    YEAST (UNII: 3NY3SM6B8U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    UREA (UNII: 8W8T17847W)  
    7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CORN OIL (UNII: 8470G57WFM)  
    VANILLA (UNII: Q74T35078H)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-078-768 in 1 PACKAGE12/19/2013
    117 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:53329-078-9148 in 1 PACKAGE12/19/201307/31/2025
    26.9 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    3NDC:53329-078-023 in 1 PACKAGE12/19/2013
    36.9 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01612/19/2013
    REMEDY BARRIER CREAM CLOTHS  FRAGRANCE FREE
    dimethicone cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-074
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE3.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    CLOVE (UNII: K48IKT5321)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ALLANTOIN (UNII: 344S277G0Z)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    COCONUT ALCOHOL (UNII: 13F4MW8Y9K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
    YEAST (UNII: 3NY3SM6B8U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    UREA (UNII: 8W8T17847W)  
    7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CORN OIL (UNII: 8470G57WFM)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-074-768 in 1 PACKAGE08/31/2016
    117 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01608/31/2016
    Labeler - Medline Industries, LP (025460908)
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