Your browser does not support JavaScript! ASSURED FEMININE ANTI-ITCH (BENZOCAINE BENZALKONIUM CHLORIDE) CREAM [GREENBRIER INTERNATIONAL]
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RxNorm Names

ASSURED FEMININE ANTI-ITCH (benzocaine benzalkonium chloride) cream
[Greenbrier International]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not 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

Benzocaine 5%

Benzalkonium Chloride .13%

Purpose

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

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

image description

ASSURED  FEMININE ANTI-ITCH
benzocaine benzalkonium chloride cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:33992-2013
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE5 g  in 100 g
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE130 mg  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 DescriptionMarketing Start DateMarketing End Date
1NDC:33992-2013-121 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/15/2013
Labeler - Greenbrier International (610322518)
Establishment
NameAddressID/FEIBusiness Operations
Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.529836561manufacture(33992-2013)

Revised: 1/2013
 
Greenbrier International

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