Your browser does not support JavaScript! EROS AQUA BASED (GLYCERIN) GEL [MEGASOL COSMETIC GMBH]
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EROS AQUA BASED (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 (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 DRUGItem 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 Description
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

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