ASSURED FEMININE ANTI-ITCH- benzocaine resorcinol cream 
Greenbrier International

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.

----------

Drug Facts

Active ingredients

Benzocaine 5%

Resorcinol 2%

Purpose

External analgesic

External analgesic

Uses

■ temporarily relieves itching

Warnings

For external use only

Avoid contact with eyes

Stop use and ask a doctor if

condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Do not apply over large areas of the body

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away

Directions

Adults and children 2 years of age and older: Apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily. Children under 2 years of age: Consult a doctor

Other information

■ Store at room temperature ■ Lot. No. & Exp. Date: See box or see crimp of tube

Inactive ingredients

Cetearyl Alcohol, Diaziolidinyl Urea, Dimethicone, Glyceryl Stearate & Peg 100 Stearate, Hydroxpropyl Bisstearyldimonium Chloride, Methyparaben, Paraffinum Liquidum,Peg 400, Propylparaben, Purified water

Package Label

Package Label

ASSURED  FEMININE ANTI-ITCH
benzocaine resorcinol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-2014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5 g  in 100 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
MINERAL OIL (UNII: T5L8T28FGP)  
HYDROXYPROPYL BISSTEARYLDIMONIUM CHLORIDE (UNII: OVB1E9X12I)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-2014-121 g in 1 TUBE; Type 0: Not a Combination Product03/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/31/2017
Labeler - Greenbrier International (610322518)
Establishment
NameAddressID/FEIBusiness Operations
FRONT PHARMACEUTICAL PLC530897792manufacture(33992-2014)

Revised: 4/2017
Document Id: 4c5a257c-51ba-44c9-e054-00144ff88e88
Set id: 4c5a257c-51b9-44c9-e054-00144ff88e88
Version: 1
Effective Time: 20170404
 
Greenbrier International