EROS ANAL EASE- glycerin 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

  • 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
LAURETH-8 (UNII: QU7U88D04I)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
LACTIC ACID (UNII: 33X04XA5AT)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53389-046-2250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/01/201201/17/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/01/201201/17/2018
Labeler - MEGASOL COSMETIC GMBH (344152855)
Establishment
NameAddressID/FEIBusiness Operations
MEGASOL COSMETIC GMBH344152855manufacture(53389-046)

Revised: 1/2018
 
MEGASOL COSMETIC GMBH