ASSURED FEMININE ANTI-ITCH- benzocaine and benzalkonium chloride 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.

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Drug Facts

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 Type HUMAN OTC DRUG Item Code (Source) NDC:33992-2013
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 5 g  in 100 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 130 mg  in 100 g
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:33992-2013-1 21 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 02/15/2013
Labeler - Greenbrier International (610322518)
Establishment
Name Address ID/FEI Business Operations
Ausmetics Daily Chemicals (Guangzhou) Co. Ltd. 529836561 manufacture(33992-2013)

Revised: 1/2013
Document Id: eecf928a-3e8a-4966-81b2-225df1dfa282
Set id: 9b07e3c4-3ae9-42c3-996c-129bb2abbd59
Version: 1
Effective Time: 20130131
 
Greenbrier International