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.

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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 Type HUMAN OTC DRUG Item Code (Source) NDC:53389-211
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 30 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53389-211-14 100 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 10/01/2012
Labeler - MEGASOL COSMETIC GMBH (344152855)
Establishment
Name Address ID/FEI Business Operations
MEGASOL COSMETIC GMBH 344152855 manufacture(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