EROS ANAL EASE- dimethicone spray 
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, laureth-9, Peg-6, caprylic/capric glycerides, menthyl lactate, lactic acid, sodium benzoate, potassium sorbate.

Eros Anal Ease Spray_MUS00046 DF Box

Eros Anal Ease Spray_MUS00046 Label

EROS ANAL EASE 
glycerin spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53389-046
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE30 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONOL (100000 CST) 
CYCLOMETHICONE 5 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53389-046-2250 mL in 1 BOTTLE, SPRAY
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(53389-046)

Revised: 12/2012
Document Id: acbdcb54-c4c2-47b1-ab3e-4979a9b47cb3
Set id: 81130145-8e39-41d2-9841-a69659584a23
Version: 2
Effective Time: 20121203
 
MEGASOL COSMETIC GMBH