M WOMANS EROS BODY GLIDE 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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ACTIVE INGREDIENT

DIMETHICONE 30%

PURPOSE

SKIN PROTECTANT

USES

  • HELPS LUBRICATING IN BODY MASSAGE

WARNING:

  • FOR EXTERNAL USE ONLY

  • KEEP OUT OF REACH OF CHILDREN

DIRECTIONS FOR USE:

  • APPLY AS NEEDED
  • OPEN THE CAP, SQUEEZE TUBE TO OBTAIN DESIRED AMOUNT OF LUBRICANT. MAY BE APPLIED DIRECTLY ONTO CONDOMS. REAPPLY AS NEEDED. CLOSE CAP AFTER USE.
  • RINSE WITH WATER TO REMOVE.

INACTIVE INGREDIENTS: DIMETHICONOL, CYCLOMETHICONE.

Eros SC Bodyglide Woman_MUS19041 DF BoxEros SC Bodyglide Woman_MUS19041 Label

M WOMANS EROS BODY GLIDE  SUPER CONCENTRATED
dimethicone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53389-190
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE30 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53389-190-14100 mL in 1 TUBE; Type 0: Not a Combination Product12/03/201201/16/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/03/201201/16/2018
Labeler - MEGASOL COSMETIC GMBH (344152855)
Establishment
NameAddressID/FEIBusiness Operations
MEGASOL COSMETIC GMBH344152855manufacture(53389-190)

Revised: 1/2018
Document Id: 42bf5055-458f-4ca3-9703-2d51a154a6d8
Set id: 6f7df27e-6548-4acf-ac8d-a7ad0c8393d6
Version: 3
Effective Time: 20180116
 
MEGASOL COSMETIC GMBH