EROS EXTENDED LOVE GLIDE 3 TOP LEVEL- glycerin gel 
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, squeeze tube to obtain desired amount of lubricant. May be applied directly onto condoms. Reapply as needed. Close cap after use.
  • Rinse with water to remove.

INACTIVE INGREDIENTS: WATER, LAURETH-9, HYDROXYPROPYL GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, HYDROXYETHYLCELLULOSE, CITRIC ACID, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN

Extended Love Glide Top Level 3_ER56103 DF Box

Extended Love Glide Top Level 3_ER56103 Label

EROS EXTENDED LOVE GLIDE  3 TOP LEVEL
glycerin gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53389-563
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)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53389-563-13100 mL in 1 TUBE; 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(53389-563)

Revised: 1/2018
 
MEGASOL COSMETIC GMBH