BENZOCAINE AND RESORCINOL - benzocaine and resorcinol ointment 
RiteAid

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 ingredient                      Purpose

Benzocaine 20%............................External analgesic
Resorcinol 3%...............................External analgesic


Active ingredient                 Purpose

Benzocaine 20%.............................External analgesic
Resorcinol 3%.................................External analgesic

Use temporarily relieves itching


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


Use
temporarily relieves itching

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

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


Directions

- adults and children 12 years and older

apply a fingertip amount (approximately 1 inch strip) to the affected area not more than 3 or 4 times daily.

- children under 12 years

ask a doctor

Other information

Store at 20 degrees to 25 degrees C (68 degrees to 77 degrees F)


Inactive Ingredients

aloe barbadebsis 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

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BENZOCAINE AND RESORCINOL 
benzocaine and resorcinol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-2890
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-2890-228 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/19/2009
Labeler - RiteAid (014578892)
Registrant - Pharma Pac, LLC (140807475)
Establishment
NameAddressID/FEIBusiness Operations
Pharma Pac, LLC140807475manufacture

Revised: 2/2011
Document Id: e8b22e2e-5f72-4520-b460-e5b423df3b3e
Set id: c694aff0-4545-40ff-8e30-bdacf70056f9
Version: 2
Effective Time: 20110216
 
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