EROS PLATINUM BODYGLIDE SUPER CONCENTRATED- dimethicone gel 
MEGASOL COSMETIC GMBH

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.

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DIMETHICONE 30%

SKIN PROTECTANT

DIMETHICONOL, CYCLOMETHICONE, VINYL DIMETHICONE CROSSPOLYMER, CYCLOPENTASILOXANE

DIRECTIONS FOR USE:

WARNINGS

KEEP OUT OF REACH OF CHILDREN

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EROS PLATINUM BODYGLIDE  SUPER CONCENTRATED
dimethicone gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 DescriptionMarketing Start DateMarketing End Date
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