EROS 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

WARNING:

DIRECTIONS FOR USE:

INACTIVE INGREDIENTS: WATER (AQUA), ETHOXYDIGLYCOL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, HYDROXYETHYLCELLULOSE, CITRIC ACID, BENZYL ALCOHOL/METHYLISOTHIAZOLINONE/METHYLCHLOROISOTHIAZOLINONE

Eros Gel Aqua Based_MUS60241 DF Box

Eros Gel Aqua Based_MUS60241 Label

EROS AQUA BASED 
glycerin gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53389-241
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (GLYCERIN) GLYCERIN30 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DIETHYLENE GLYCOL MONOETHYL ETHER 
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) 
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) 
ANHYDROUS CITRIC ACID 
BENZYL ALCOHOL 
METHYLISOTHIAZOLINONE 
METHYLCHLOROISOTHIAZOLINONE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53389-241-13100 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/01/2012
Labeler - MEGASOL COSMETIC GMBH (344152855)
Establishment
NameAddressID/FEIBusiness Operations
MEGASOL COSMETIC GMBH344152855manufacture(53389-241)

Revised: 12/2012
Document Id: 2744e70b-4af2-462c-b35c-0d5806d440f0
Set id: 65c9907f-f90d-4f04-aa15-deb75ab9360b
Version: 3
Effective Time: 20121203
 
MEGASOL COSMETIC GMBH