Label: SENSI-CARE- dimethicon, zinc oxide cream

  • NDC Code(s): 53329-769-14, 53329-769-64
  • 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 August 17, 2023

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

View All Sections
  • Active ingredient

    Dimethicone 5% w/w

    Zinc oxide 5% w/w

  • Purpose

    Skin protectant

  • Uses

    • helps treat and prevent diaper rash
    • protects minor skin irritation associated with diaper rash and helps seal out wetness
  • Warnings

    For external use only.

    Do not use

    • on deep or puncture wounds
    • on animal bites
    • on 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 consult a Poison Control Center right away.

  • Directions

    • change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
    • apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
  • Other information

    • store at 15°C-30°C (59°F-86°F)
    • *for infacts/neonates, please use under medical supervision
  • Inactive ingredients

    butylene/ethylene/styrene copolymer, calamine, carthamus tinctorius (safflower) oleosomes, cellulose gum, cocos nucifera (coconut) oil, ethylene/propylene/styrene copolymer, gelatin, gossypium herbaceum (cotton) seed oil, hydrolyzed collagen, lanolin, microcrystalline wax, mineral oil, oleic acid, pectin, phenoxyethanol, punica granatum sterols, simmondsia chinensis (jojoba) seed oil, sodium hyaluronate, steric acid, theobroma cacao (cocoa) seed butter, tocopheryl acetate, water

  • Manufacturing Information

    Manufactured for Medline Industries, LP

    Three Lakes Drive, Northfiels, IL 60093 USA

    Made in USA of foreign and domestic materials

    www.medline.com

    1-800-MEDLINE

    REF: 413586

    V1 RE21AXQ

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    SENSI-CARE 
    dimethicon, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-769
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 g  in 100 g
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    PUNICA GRANATUM STEROLS (UNII: UKV92KC49T)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    LEVANT COTTONSEED OIL (UNII: N5CFT140R8)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PECTIN (UNII: 89NA02M4RX)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-769-1456 g in 1 TUBE; Type 0: Not a Combination Product09/30/202012/31/2024
    2NDC:53329-769-64141 g in 1 TUBE; Type 0: Not a Combination Product09/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01609/30/2020
    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!