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.

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DIMETHICONE 30%

SKIN PROTECTANT

  • HELPS LUBRICATING IN BODY MASSAGE

DIMETHICONOL, CYCLOMETHICONE, VINYL DIMETHICONE CROSSPOLYMER, CYCLOPENTASILOXANE

DIRECTIONS FOR USE:

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

WARNINGS

  • FOR EXTERNAL USE ONLY
  • STOP USE AND ASK DOCTOR IF RASH OR IRRITATION DELOVELOPES AND LASTS.

KEEP OUT OF REACH OF CHILDREN

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EROS PLATINUM BODYGLIDE  SUPER CONCENTRATED
dimethicone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53389-000
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 (UNII: NMQ347994Z)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (UNII: 9E4CO0W6C5)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53389-000-13100 mL in 1 TUBE; Type 0: Not a Combination Product11/01/201201/16/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34711/01/201201/16/2018
Labeler - MEGASOL COSMETIC GMBH (344152855)
Establishment
NameAddressID/FEIBusiness Operations
MEGASOL COSMETIC GMBH344152855manufacture(53389-000)

Revised: 1/2018
 
MEGASOL COSMETIC GMBH