EROS

Main information

  • Trade name:
  • EROS FISTING GEL SLIDE X glycerin
  • Composition:
  • GLYCERIN 5 g in 100 mL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • EROS FISTING GEL SLIDE X glycerin
    United States
  • Language:
  • English

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph not final
  • Last update:
  • 06-11-2017

Summary of Product characteristics: dosage, interactions, side effects

EROS FISTING GEL SLIDE X- 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

INACTIVE INGREDIENTS: WATER, PROPYLENE GLYCOL, CYCLOMETHICONE, SODIUM

ACRYLATE/ACRYLOYLDIMETHYL TAURATE, DIMETHICONOL, ISOHEXADECANE,

POLYSORBATE 80, HYDROXYETHYLCELLULOSE, PHENOXYETHANOL,

ETHYLHEXYLGLYCERIN

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 CP AFTER

USE.

RINSE WITH WATER TO REMOVE.

EROS FISTING GEL SLIDE X

glycerin gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:5338 9 -512

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX) (GLYCERIN - UNII:PDC6 A3C0 OX)

GLYCERIN

5 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

CYCLO METHICO NE (UNII: NMQ3479 9 4Z)

SO DIUM ACRYLATE/SO DIUM ACRYLO YLDIMETHYLTAURATE CO PO LYMER ( 4 0 0 0 0 0 0 MW) (UNII:

1DXE3F3OZX)

DIMETHICO NO L ( 2 0 0 0 CST) (UNII: T74O12AN6 Y)

ISO HEXADECANE (UNII: 9 18 X1OUF1E)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

HYDRO XYETHYL CELLULO SE ( 10 0 MPA.S AT 2 %) (UNII: R33S7TK2EP)

MEGASOL COSMETIC GMBH

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:5338 9 -512-17

20 0 mL in 1 TUBE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt347

10 /0 1/20 12

Labeler -

MEGASOL COSMET IC GMBH (344152855)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

MEGASOL COSMETIC GMBH

3441528 55

ma nufa c ture (5338 9 -512)

Revised: 3/2013