EROS PLATINUM 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.

----------

DIMETHICONE 30%

SKIN PROTECTANT

DIMETHICONOL, CYCLOMETHICONE, VINYL DIMETHICONE CROSSPOLYMER, CYCLOPENTASILOXANE

DIRECTIONS FOR USE:

WARNINGS

KEEP OUT OF REACH OF CHILDREN

image description

image description

EROS PLATINUM BODYGLIDE  SUPER CONCENTRATED
dimethicone gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53389-000
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 (UNII: NMQ347994Z)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (UNII: 9E4CO0W6C5)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53389-000-13 100 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 11/01/2012
Labeler - MEGASOL COSMETIC GMBH (344152855)
Establishment
Name Address ID/FEI Business Operations
MEGASOL COSMETIC GMBH 344152855 manufacture(53389-000)

Revised: 12/2012
Document Id: c48e362d-8c2c-4bf7-b09e-230c946f49ee
Set id: a0ade6a5-6403-4c00-bc07-2439c6218b67
Version: 3
Effective Time: 20121204
 
MEGASOL COSMETIC GMBH