M EROS LIQUID AQUA BASED- glycerin 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

GLYCERIN 5%

PURPOSE

SKIN PROTECTANT

USES

HELPS LUBRICATING IN BODY MASSAGE

WARNINGS

DIRECTIONS FOR USE

INACTIVE INGREDIENTS

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 gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53389-600
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 5 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:53389-600-14 250 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)
Establishment
Name Address ID/FEI Business Operations
MEGASOL COSMETIC GMBH 344152855 manufacture(53389-600)

Revised: 12/2012
Document Id: 1d1713c4-b15d-414a-9fb0-f25dd1e513df
Set id: 83ac7cdf-6515-439d-b523-8e9f89844f43
Version: 1
Effective Time: 20121201
 
MEGASOL COSMETIC GMBH