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EROS ANAL EASE

Dosage form: spray
Ingredients: DIMETHICONE 30g in 100mL
Labeler: MEGASOL COSMETIC GMBH
NDC Code: 53389-046

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

  • 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 
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/FEIOperations
MEGASOL COSMETIC GMBH344152855manufacture(53389-046)

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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