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 Type HUMAN OTC DRUG Item Code (Source) NDC:53389-241
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 30 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53389-241-13 100 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 10/01/2012
Labeler - MEGASOL COSMETIC GMBH (344152855)
Establishment
Name Address ID/FEI Business Operations
MEGASOL COSMETIC GMBH 344152855 manufacture(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