BENZOCAINE AND RESORCINOL - benzocaine and resorcinol 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.

----------

drug facts

Active ingredients                      Purpose
Benzocaine 20%....................External Analgesic
Resorcinol 3%........................External Analgesic

Usetemporarily relieves itching


Keep out of reach of children. If swallowed, get medical help or contact
a Poison Control Center right away.

Use temporarily relieves itching

Other information - store at 20 degrees - 25 degrees C (68 degrees - 77 degrees F)

Warnings
For external use only.
_______________________________________________________________

When using this product avoid contact with the 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
_______________________________________________________________


Directions  adults and                       apply a fingertip amount (approximately
                   children 12 years             1 inch strip) to the affected area not
                   and older                         more than 3 to 4 times daily
                   _______________________________________________________
                  
                   children under 12 years    ask a doctor

Inactive Ingredients aloe barbadensis leaf extract, carbomer, cetyl
alcohol, cholecalciferol, fragrance, glyceryl stearate, isopropyl myristate, isopropyl
palmitate, isopropyl stearate, lanolin alcohol, methylparaben, mineral oil, PEG-100
stearate, propylene glycol, purified water, retinyl palmitate, sodium sulfite, tocopheryl
acetate, trisodium HEDTA, triethanolamine, zea mays (corn) oil

label


BENZOCAINE AND RESORCINOL 
benzocaine and resorcinol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-810
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ISOPROPYL STEARATE (UNII: 43253ZW1MZ)  
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
VITAMIN A (UNII: 81G40H8B0T)  
VITAMIN D (UNII: 9VU1KI44GP)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SODIUM SULFITE (UNII: VTK01UQK3G)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
TRISODIUM HEDTA (UNII: K3E0U7O8KI)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CORN OIL (UNII: 8470G57WFM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-810-241 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/19/2009
Labeler - CVS Pharmacy (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 2/2011
Document Id: fa434f3c-a4ea-4745-8206-abaeff14054d
Set id: 2e202ba9-191e-4b2c-8ec0-e187fdbbab06
Version: 5
Effective Time: 20110216
 
CVS Pharmacy