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 Type HUMAN OTC DRUG Item Code (Source) NDC:53389-410
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:53389-410-13 100 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(53389-410)

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