EROS EXPLORER MAN- 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

  • HELPS LUBRICATING IN BODY MASSAGE

WARNING:

  • FOR EXTERNAL USE ONLY
  • STOP USE AND ASK A DOCTOR IF RASH OR IRRITATION DEVELOPS AND LASTS.

  • KEEP OUT OF REACH OF CHILDREN

Directions for use:

  • Apply as needed
  • Open the cap. Apply 1 or 2 sprays to the anus. Wait briefly. Reapply as needed. Close cap after use.
  • Rinse with water to remove.

Inactive Ingredients: Water, laureth-9, PEG-6 caprylic/capric glycerides, menthyl lactate, lactic acid, parfum (fragrance), benzyl alcohol, benzoic acid, sorbic acid.

Explorer Man_ER53030 DF Box

Explorer Man_ER53030 Label

EROS EXPLORER  MAN
glycerin spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53389-530
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)  
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
LACTIC ACID (UNII: 33X04XA5AT)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SORBIC ACID (UNII: X045WJ989B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53389-530-1330 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/01/201201/16/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34710/01/201201/16/2018
Labeler - MEGASOL COSMETIC GMBH (344152855)
Establishment
NameAddressID/FEIBusiness Operations
MEGASOL COSMETIC GMBH344152855manufacture(53389-530)

Revised: 1/2018
Document Id: 4e9bac9f-7f19-4c84-8266-6806cdb0093f
Set id: 5bed289d-ae4a-4bf1-8bef-b2dd0a1cc3d3
Version: 3
Effective Time: 20180116
 
MEGASOL COSMETIC GMBH