Your browser does not support JavaScript! EROS ANAL EASE (GLYCERIN) SPRAY [MEGASOL COSMETIC GMBH]
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EROS ANAL EASE (glycerin) spray
[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

  • Protects skin from irritation.

Warning:

  • For external use only.
  • Use only in the anal region.
  • Avoid contact with eyes.

  • KEEP OUT OF REACH OF CHILDREN

Directions for use:

  • Apply 1 or 2 sprays to the anus and allow a short time to take effect.

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 DRUGItem 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 Description
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

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