EROS CLASSIC SILICONE BODYGLIDE- 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.

----------

ACTIVE INGREDIENT

DIMETHICONE 30%

PURPOSE

SKIN PROTECTANT

USES

WARNING:

DIRECTIONS FOR USE:

INACTIVE INGREDIENTS: DIMETHICONOL, CYCLOMETHICONE.

Eros Classic Silicone Bodyglide_ER21100 DF Box

Eros Classic Silicone Bodyglide_ER21100 Label

EROS CLASSIC SILICONE BODYGLIDE 
dimethicone gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53389-211
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 5 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53389-211-14100 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/01/2012
Labeler - MEGASOL COSMETIC GMBH (344152855)
Establishment
NameAddressID/FEIBusiness Operations
MEGASOL COSMETIC GMBH344152855manufacture(53389-211)

Revised: 12/2012
Document Id: efd5e487-3bc5-4108-a5c4-8c68d68619cc
Set id: dfce51b0-f69e-484d-a561-649e86d46121
Version: 2
Effective Time: 20121201
 
MEGASOL COSMETIC GMBH