Label: CLARA 1984- dimethicone cream

  • 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 January 9, 2015

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient: DIMETHICONE 1.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Vaseline, Sophora Japanese, Myrobalan, Ginger, Madder, Akanthopanax, Gomphocarpus, Zigadenus, Liquidambar, Aristolochia, Anacamptis, Cinnamon, Saffron powder, Wild rose, Peppermint, violet , Olive

  • PURPOSE

    Purpose: Skin Moisturizing, Protection

  • WARNINGS

    Warnings:
    During the summer time store in refrigerator. and Place product at room temperature for else seasons. /
    Not recommended for children under 4 years. / Expiration period: 2 years

  • KEEP OUT OF REACH OF CHILDREN

    Not recommended for children under 4 years.

  • INDICATIONS & USAGE

    Indications and Usage:
    Spread thoroughly for full moisture.

  • DOSAGE & ADMINISTRATION

    Dosage and Administration:
    Take an adequate amount of this product.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    CLARA 1984 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69404-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.5 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Cinnamon (UNII: 5S29HWU6QB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69404-010-0150 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/20/2014
    Labeler - CLARA GROUP (689060172)
    Registrant - CLARA GROUP (689060172)
    Establishment
    NameAddressID/FEIBusiness Operations
    CLARA GROUP689060172manufacture(69404-010)
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!