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Name:Benzocaine And Resorcinol
Manufacturer:Cvs Pharmacy
Category:Over-the-counter (OTC) Marketed Drugs


drug facts

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.

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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 Type HUMAN OTC DRUG Item Code (Source) NDC:59779-810
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 200 mg  in 1 g
RESORCINOL (RESORCINOL) RESORCINOL 20 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
CARBOMER HOMOPOLYMER TYPE C  
CETYL ALCOHOL  
GLYCERYL MONOSTEARATE  
ISOPROPYL PALMITATE  
ISOPROPYL MYRISTATE  
ISOPROPYL STEARATE  
LANOLIN ALCOHOLS  
MINERAL OIL  
POLYOXYL 100 STEARATE  
VITAMIN A  
VITAMIN D  
ALOE VERA LEAF  
SODIUM SULFITE  
ALPHA-TOCOPHEROL  
TRISODIUM HEDTA  
METHYLPARABEN  
PROPYLENE GLYCOL  
CORN OIL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-810-24 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 28 g in 1 TUBE This package is contained within the CARTON (59779-810-24)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 05/19/2009

Labeler - CVS Pharmacy (062312574)
Registrant - Pharma Pac, LLC (140807475)
Establishment
Name Address ID/FEI Operations
Pharma Pac, LLC 140807475 manufacture

Revised: 02/2011 CVS Pharmacy



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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