BENZOCAINE AND RESORCINOL - benzocaine and resorcinol cream 
Dolgencorp, inc

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

Use temporarily 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.
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When using this product avoid contact with the eyes
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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
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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.
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Directions 
adults and children 12 years and older                       
    apply a fingertip amount (approximately 1 inch strip) to the affected area not more than 3 to 4 times daily
                 
children under 12 years   
    ask a doctor

Inactive Ingredients aloe barbadensis leaf extract, carbomer 940, cetyl alcohol, cholecalciferol, fragrance, glyceryl monostearate,
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, trolamine, zea mays (corn) oil

label


BENZOCAINE AND RESORCINOL 
benzocaine and resorcinol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-185
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:55910-185-0328 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/19/2009
Labeler - Dolgencorp, inc (068331990)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 7/2011
Document Id: 1696c10c-25a1-4ea3-bdfb-374e53f0f12d
Set id: 78e994ff-5a7f-4e69-8a93-552a132668a7
Version: 1
Effective Time: 20110701
 
Dolgencorp, inc