EROS EXTENDED LOVE 2 TOP LEVEL- 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 - 3 sprays, rub in. 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, panthenol, bisabolol, PEG-40 hydrogenated castor oil, benzyl alcohol, benzoic acid, sorbic acid.

Extended Love Top Level 2 spray_ER57032 DF Box

Extended Love Top Level 2 spray_ER57032 Label

EROS EXTENDED LOVE  2 TOP LEVEL
glycerin spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53389-572
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)  
LACTIC ACID (UNII: 33X04XA5AT)  
PANTHENOL (UNII: WV9CM0O67Z)  
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SORBIC ACID (UNII: X045WJ989B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53389-572-2130 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(53389-572)

Revised: 1/2018
Document Id: 5caa6dd1-e8cb-48a2-955e-b06b9e1b4933
Set id: 308c031c-70ca-4e40-bcde-dea6a549574f
Version: 3
Effective Time: 20180116
 
MEGASOL COSMETIC GMBH