EROS AQUA - 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, HYDROXYPROPYL GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, HYDROXYETHYLCELLULOSE, CITRIC ACID, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN.

Aqua_ER33101 DF Box

Aqua_ER33101 Label

EROS AQUA 
glycerin gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53389-331
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)  
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53389-331-13 100 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(53389-331)

Revised: 11/2012
Document Id: 6c831baf-c867-441e-a65e-7d50eb8c1a61
Set id: 1c5b7ecb-4238-43d8-a1eb-f6863cdc067b
Version: 1
Effective Time: 20121109
 
MEGASOL COSMETIC GMBH