Label: MEDLINE REMEDY PHYTOPLEX SKIN REPAIR- dimethicone cream

  • NDC Code(s): 53329-152-04, 53329-152-14, 53329-152-17, 53329-152-44, view more
    53329-152-64, 53329-152-84
  • 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 September 27, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredient

    Dimethicone 5%

  • Purpose

    Skin protectant

  • Uses

    • Temporarily protects and helps relieve chapped or cracked skin. Protects from the drying effects of wind and cold weather.
  • Warnings

    For External Use Only.

    Do not use

    • on deep or puncture wounds
    • on animal bites
    • on serious burns

    When using this product

    • avoid contact with eyes.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last for 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

    • apply as needed
  • Other information

    • Protect from freezing. Avoid excessive heat.
  • Inactive ingredients

    algae extract, bisabolol, brassica campestris (rapeseed) sterols, camellia sinensis (green tea) leaf extract, caprylic/capric triglycerides, caprylyl glycol, carthamus tinctorius (safflower) oleosomes, cetylhydroxyproline palmitamide, cholecalciferol, citrus paradisi (grapefruit) peel oil, citrus reticulata (tangerine) peel oil, citrus sinensis (orange) peel oil, cetyl alcohol, cocos nucifera (coconut oil),
    7-dehydrocholesterol, ethylene brassylate, eugenia caryophyllus (clove) flower extract, glycerin, glyceryl stearate, glycol distearate, 1,2-hexanediol, hexyldecanol, hydrolyzed soy protein, hydroyacetophenone, isopropyl myristate, jojoba esters, manuka honey, methyldihydrojasmonate, olea europaea (olive oil), peg 100 stearate, phospholipids, phytonadione, purified water, propanediol, stearic acid, tocopherol acetate, vanilla planifolia extract, yeast ferment extract, zea mays (corn) oil.

  • Manufacturing Information

    Phytoplex, Medline Remedy, and Medline are registered trademarks of Medline Industries Inc. Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60093 USA. Made in USA of domestic and imported materials.

    www.medline.com 1-800-MEDLINE

    RK20BLB

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    MEDLINE REMEDY PHYTOPLEX SKIN REPAIR 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-152
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GELIDIELLA ACEROSA (UNII: T91K54D6M1)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)  
    HONEY (UNII: Y9H1V576FH)  
    PHYTONADIONE (UNII: A034SE7857)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    CLOVE (UNII: K48IKT5321)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    MANDARIN OIL (UNII: NJO720F72R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXYLDECANOL (UNII: 151Z7P1317)  
    .BETA.-BISABOLOL (UNII: LP618AV2EA)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    RAPESEED STEROL (UNII: B46B6DD20U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    VANILLIN (UNII: CHI530446X)  
    WATER (UNII: 059QF0KO0R)  
    CORN OIL (UNII: 8470G57WFM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-152-1459 mL in 1 TUBE; Type 0: Not a Combination Product02/12/2018
    2NDC:53329-152-44118 mL in 1 TUBE; Type 0: Not a Combination Product02/12/2018
    3NDC:53329-152-64946.353 mL in 1 TUBE; Type 0: Not a Combination Product04/03/2018
    4NDC:53329-152-17144 in 1 BOX04/03/2018
    4NDC:53329-152-044.14 mL in 1 PACKET; Type 0: Not a Combination Product
    5NDC:53329-152-841000 mL in 1 BOTTLE; Type 0: Not a Combination Product02/12/2019
    6NDC:53329-152-044.14 mL in 1 PACKET; Type 0: Not a Combination Product02/12/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01602/12/2018
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!