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Assured

Greenbrier International

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

Active Ingredient

Benzocaine 5%

Benzalkonium Chloride .13%

Purpose

Purpose

External analgesic

Uses

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

Assured

Assured

Benzocaine Benzalkonium chloride CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:33992-2013
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOCAINE Benzocaine 5 g
benzalkonium chloride 130 mg

Inactive Ingredients

Ingredient Name Strength
water
polyethylene glycol 400
CETOSTEARYL ALCOHOL
Mineral Oil
HYDROXYPROPYL BISSTEARYLDIMONIUM CHLORIDE
DIMETHICONE
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
DIAZOLIDINYL UREA
METHYLPARABEN
PROPYLPARABEN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:33992-2013-1 21 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2013-02-15


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Be sure to consult your doctor before taking any medication!
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