EROS ANAL SILICONE - 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 Anal silcone_MUS11410 Drug Facts Box

Eros Anal silcone_MUS11410 Label

EROS ANAL SILICONE 
dimethicone gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53389-410
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:53389-410-13100 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(53389-410)

Revised: 12/2012
Document Id: 8a2c4d26-bbca-41be-bde0-af6167a681c0
Set id: de7dca2d-f7fd-4723-a314-0c08c1bf47d8
Version: 2
Effective Time: 20121201
 
MEGASOL COSMETIC GMBH