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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53389-331
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (GLYCERIN) GLYCERIN30 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) 
CETYL HYDROXYETHYLCELLULOSE (350000 MW) 
ANHYDROUS CITRIC ACID 
PHENOXYETHANOL 
ETHYLHEXYLGLYCERIN 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53389-331-13100 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(53389-331)

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