Your browser does not support JavaScript! EROS PLATINUM BODYGLIDE SUPER CONCENTRATED (DIMETHICONE) GEL [MEGASOL COSMETIC GMBH]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

EROS PLATINUM BODYGLIDE SUPER CONCENTRATED (dimethicone) gel
[MEGASOL COSMETIC GMBH]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

DIMETHICONE 30%

SKIN PROTECTANT

  • HELPS LUBRICATING IN BODY MASSAGE

DIMETHICONOL, CYCLOMETHICONE, VINYL DIMETHICONE CROSSPOLYMER, CYCLOPENTASILOXANE

DIRECTIONS FOR USE:

  • APPLY AS NEEDED.
  • OPEN THE CAP, SQUEEZE TUBE TO OBTAIN DESIRED AMOUNT OF LUBRICANT. MAY BE APPLIED DIRECTLY TO CONDOMS. REAPPLY AS NEEDED. CLOSE CAP AFTER USE.
  • RINSE WITH WATER TO REMOVE.

WARNINGS

  • FOR EXTERNAL USE ONLY
  • STOP USE AND ASK DOCTOR IF RASH OR IRRITATION DELOVELOPES AND LASTS.

KEEP OUT OF REACH OF CHILDREN

image description

image description

EROS PLATINUM BODYGLIDE  SUPER CONCENTRATED
dimethicone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53389-000
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE30 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONOL (100000 CST) 
CYCLOMETHICONE 
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER 
CYCLOMETHICONE 5 
Packaging
#Item CodePackage Description
1NDC:53389-000-13100 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/01/2012
Labeler - MEGASOL COSMETIC GMBH (344152855)
Establishment
NameAddressID/FEIBusiness Operations
MEGASOL COSMETIC GMBH344152855manufacture(53389-000)

Revised: 12/2012
Document Id: c48e362d-8c2c-4bf7-b09e-230c946f49ee
Set id: a0ade6a5-6403-4c00-bc07-2439c6218b67
Version: 3
Effective Time: 20121204
 
MEGASOL COSMETIC GMBH

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services