M 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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USES:

MAY BE APPLIED DIRECTLY ONTO CONDOMS. REAPPLY AS NEEDED. CLOSE CAP AFTER USE.

USES

KEEP OUT OF REACH OF CHILDREN

DIMETHICONE 30%

DIMETHICONOL, CYCLOMETHICONE

SC Bodyglide_MUS11041 Drug Facts Box

SC Bodyglide_MUS11041 Label

M EROS BODYGLIDE  .SUPER CONCENTRATED
dimethicone gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53389-110
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)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53389-110-14 100 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 12/01/2012
Labeler - MEGASOL COSMETIC GMBH (344152855)
Registrant - MEGASOL COSMETIC GMBH (344152855)
Establishment
Name Address ID/FEI Business Operations
MEGASOL COSMETIC GMBH 344152855 manufacture(53389-110)

Revised: 12/2012
Document Id: 4d726637-95ed-4cbe-b4e1-e9bd5d5cf065
Set id: 1bd82730-22ae-4e5a-9781-4dd08d631671
Version: 1
Effective Time: 20121201
 
MEGASOL COSMETIC GMBH