EROS 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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ACTIVE INGREDIENT

DIMETHICONE 30%

PURPOSE

SKIN PROTECTANT

USES

WARNING:

DIRECTIONS FOR USE:

INACTIVE INGREDIENTS: DIMETHICONOL, CYCLOMETHICONE.

Drug Facts Box_Eros Bodyglide Super Concentrated_ER10100

Label_Eros Bodyglide Super Concentrated_ER10100

EROS BODYGLIDE  SUPER CONCENTRATED
dimethicone gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53389-035
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:53389-035-14100 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(53389-035)

Revised: 11/2012
Document Id: bf897f0b-2187-43ee-8750-b6169a2549c3
Set id: c2983e77-c70c-4326-b5cb-1657c5b8c2b1
Version: 2
Effective Time: 20121109
 
MEGASOL COSMETIC GMBH