CVS PHARMACY SENSITIVE MEDICATED CREAM- benzocaine, benzalkonium chloride cream 
CVS Pharmacy

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 0.13%

Purpose

Topical Analgesic

First Aid Antiseptic

Uses

First aid temporary relief from the discomforts affecting the external area surrounding the vagina:

Warnings

For external use only.

Do not use if you have unusual or abnormal vaginal discharge except under the supervision of your doctor.

When using this product

  • Wash hand thoroughly with soap and water before and after use
  • Avoid contact with eyes.
  • If burning sensation occurs and lasts more than a few minutes remove the cream and discontinue use.
  • Do not use more than 1 week unless directed by a doctor

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.
  • side effect occur. You may report sude effect to FDA at 1-800-FDA-1088

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately. If in eyes, flush with water for 15 minutes and call a physician.

Store at room temperature. For lot number and expiration dates see crimp of tube or side of box.

Deionized Water, Glycerol Monostearate, Mineral Oil, PEG 100 Stearate, Cetyl Alcohol, Fragrance, Aloe Vera Gel, Lanolin Alcohol, Isopropyl Myristate, Isopropyl Stearate, Isopropyl Palmitate, Triethanolamine, Methylparaben, Propylparaben, Carbomer, Tocopheryl Acetate (Vitamin E), Trisodium HEDTA.

Questions or Comments

1-800-635-3696

tube and carton

CVS PHARMACY  SENSITIVE MEDICATED CREAM
benzocaine, benzalkonium chloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-638
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.05 g  in 1 g
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0013 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
WATER (UNII: 059QF0KO0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ISOPROPYL STEARATE (UNII: 43253ZW1MZ)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
TRISODIUM HEDTA (UNII: K3E0U7O8KI)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-638-011 in 1 CARTON05/01/2005
142.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/01/2005
Labeler - CVS Pharmacy (062312574)

Revised: 1/2017
Document Id: 45d94180-4436-7298-e054-00144ff88e88
Set id: 454c3458-7e40-0e5e-e054-00144ff8d46c
Version: 2
Effective Time: 20170104
 
CVS Pharmacy