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Assured Feminine Anti-itch by Greenbrier International

Medically reviewed on April 4, 2017

Dosage form: cream
Ingredients: BENZOCAINE 5g in 100g, RESORCINOL 2g in 100g
Labeler: Greenbrier International
NDC Code: 33992-2014

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

ASSURED  FEMININE ANTI-ITCH
benzocaine resorcinol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-2014
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE5 g  in 100 g
RESORCINOL (RESORCINOL) RESORCINOL2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
POLYETHYLENE GLYCOL 400 
CETOSTEARYL ALCOHOL 
MINERAL OIL 
HYDROXYPROPYL BISSTEARYLDIMONIUM CHLORIDE 
DIMETHICONE 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
DIAZOLIDINYL UREA 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:33992-2014-121 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/31/2017
Labeler - Greenbrier International (610322518)
Establishment
NameAddressID/FEIOperations
FRONT PHARMACEUTICAL PLC530897792manufacture(33992-2014)

 
Greenbrier International

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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