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EROS AQUA BASED

Dosage form: gel
Ingredients: GLYCERIN 30g in 100mL
Labeler: MEGASOL COSMETIC GMBH
NDC Code: 53389-241

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.

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 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/FEIOperations
MEGASOL COSMETIC GMBH344152855manufacture(53389-241)

Revised: 12/2012
 
MEGASOL COSMETIC GMBH

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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