Pillstats
OTC · Cloth · Topical

Dimethicone

Brands: Aloetouch Protect Fragrance Free · Comfort Shield Barrier · Medichoice Barrier · Personal Cleansing With Dimethicone +4 · Dimethicone

4 ACTIVE SUPPLIERS — US
openFDA · updated weekly
US9 NDCs
4 active makers
UKComing
soon
CAComing
soon
AUComing
soon
EUComing
soon
ATCP03AX05
RxCUI (US)324072
US makers4 labelers
Packages16
DEA / ScheduleNone

Medicaid dispensing volume

No Medicaid utilization on record for this drug concept yet. Quarterly volume (CMS State Drug Utilization Data) loads with the utilization ETL.

Who makes it4 active · 0 exited

US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.

LabelerTypePackagesStatus
Medline Industries, LPunknown7SUPPLYING
O&M HALYARD, INC.unknown4SUPPLYING
Sage Products LLCunknown4SUPPLYING
Cardinal Health 200, Incunknown1SUPPLYING

Regulatory & supply eventsFDA · US

Shortages, recalls, and registration changes attached to this drug concept.

  • Jul 29, 2016
    RECALLRecall (Class II): COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, fu…

    CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product. — Recalling firm: Sage Products LLC — Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mex…

  • Jul 29, 2016
    RECALLRecall (Class I): COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, fu…

    Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia. — Recalling firm: Sage Products LLC — Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mex…

  • Aug 27, 2014
    RECALLRecall (Class II): Comfort Shield Barrier Cream Cloths with dimethicone a) 8 count NDC 53462-915-80, b) 24 count NDC 53462-915-60, OTC, SA…

    Microbial Contamination of Non-Sterile Products: Comfort Shield Barrier Cream Cloth packages tested positive for bacterial contamination. — Recalling firm: Sage Products Inc — Nationwide