MAKESENSE FEMININE ANTI-ITCH- benzocaine benzalkonium chloride cream
Cherry Hill Sales Co

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 Ingredients

Benzocaine 5%

Benzalkonium Chloride .13%

Purpose

External Analgesic

External Antiseptic

Uses

■ temporarily relieves itching

Warnings

For external use only

Avoid contact with eyes

Stop use and ask a doctor

■ condition or symptoms worsens ■ symptoms do not improve in 7 days ■ if symptoms 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

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

Package Label

image description

MAKESENSE FEMININE ANTI-ITCH
benzocaine benzalkonium chloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69020-209
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROXYPROPYL BISSTEARYLDIMONIUM CHLORIDE (UNII: OVB1E9X12I)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69020-209-21	21 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	07/31/2014

Labeler - Cherry Hill Sales Co (145959768)