Your browser does not support JavaScript! EROS ANAL SILICONE (DIMETHICONE) GEL [MEGASOL COSMETIC GMBH]
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EROS ANAL SILICONE (dimethicone) gel
[MEGASOL COSMETIC GMBH]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

ACTIVE INGREDIENT

DIMETHICONE 30%

PURPOSE

SKIN PROTECTANT

USES

  • HELPS LUBRICATING IN BODY MASSAGE

WARNING:

  • FOR EXTERNAL USE ONLY

  • KEEP OUT OF REACH OF CHILDREN

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

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: DIMETHICONOL, CYCLOMETHICONE.

Eros Anal silcone_MUS11410 Drug Facts Box

Eros Anal silcone_MUS11410 Label

EROS ANAL SILICONE 
dimethicone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53389-410
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:53389-410-13100 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/01/2012
Labeler - MEGASOL COSMETIC GMBH (344152855)
Establishment
NameAddressID/FEIBusiness Operations
MEGASOL COSMETIC GMBH344152855manufacture(53389-410)

Revised: 12/2012
Document Id: 8a2c4d26-bbca-41be-bde0-af6167a681c0
Set id: de7dca2d-f7fd-4723-a314-0c08c1bf47d8
Version: 2
Effective Time: 20121201
 
MEGASOL COSMETIC GMBH

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