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 Type HUMAN OTC DRUG Item Code (Source) NDC:53389-046
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 30 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53389-046-22 50 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 10/01/2012
Labeler - MEGASOL COSMETIC GMBH (344152855)
Establishment
Name Address ID/FEI Business Operations
MEGASOL COSMETIC GMBH 344152855 manufacture(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