M EROS LIQUID AQUA BASED- glycerin solution 
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

GLYCERIN 5%

PURPOSE

SKIN PROTECTANT

USES

HELPS LUBRICATING IN BODY MASSAGE

WARNINGS

  • FOR EXTERNAL USE ONLY
  • STOP AND ASK DOCTOR IF RASH OR IRRATION DEVELOPES AND LASTS.

DIRECTIONS FOR USE

  • APPLY AS NEEDED
  • OPEN 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

  • WATER
  • HYDROXYPROPYL GUAR
  • HYDROXYPROPYLTRIMONIUM CLORIDE
  • HYDROXYETHYLCELLULOSE
  • CITRIC ACIS
  • PHENOXYETHANOL
  • ETHYLHEXLGLYCERIN

KEEP OUT OF REACH OF CHILDREN

Eros Liquid Aqua Based_MUS60061 DF Box

Eros Liquid Aqua Based_MUS60061 Label

M EROS LIQUID  AQUA BASED
glycerin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53389-600
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
DIHYDROXYPROPYLTRIMONIUM CHLORIDE (UNII: V5RP514IX5)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53389-600-14250 mL in 1 TUBE; Type 0: Not a Combination Product12/01/201201/16/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34712/01/201201/16/2018
Labeler - MEGASOL COSMETIC GMBH (344152855)
Establishment
NameAddressID/FEIBusiness Operations
MEGASOL COSMETIC GMBH344152855manufacture(53389-600)

Revised: 1/2018
Document Id: e8087ce8-fb48-4319-8e86-810ffaf1a5fc
Set id: 83ac7cdf-6515-439d-b523-8e9f89844f43
Version: 2
Effective Time: 20180116
 
MEGASOL COSMETIC GMBH