Your browser does not support JavaScript! EROS AQUA (GLYCERIN) GEL [MEGASOL COSMETIC GMBH]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

Not yet provided

EROS AQUA (glycerin) gel
[MEGASOL COSMETIC GMBH]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

ACTIVE INGREDIENT

GLYCERIN 5%

PURPOSE

SKIN PROTECTANT

USES

  • HELPS LUBRICATING IN BODY MASSAGE

WARNING:

  • FOR EXTERNAL USE ONLY

  • KEEP OUT OF REACH OF CHILDREN

  • STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS.

DIRECTIONS FOR USE:

  • APPLY AS NEEDED
  • OPEN THE CAP, SQUEEZE TUBE TO OBTAIN DESIRED AMOUNT OF LUBRICANT. MAY BE APPLIED DIRECTLY ONTO CONDOMS. REAPPLY AS NEEDED. CLOSE CAP AFTER USE.
  • RINSE WITH WATER TO REMOVE.

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 DRUGItem 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 Description
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

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services