BENZOCAINE and RESORCINOL: Package Insert and Label Information

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.

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.
_______________________________________________________________________________________________________________________
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 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 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
(click image for full-size original)
BENZOCAINE AND RESORCINOL benzocaine and resorcinol cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-185
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
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55910-185-03 28 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 05/19/2009
Labeler — Dolgencorp, inc (068331990)
Registrant — Pharma Pac, LLC (140807475)
Establishment
Name Address ID/FEI Operations
Pharma Pac, LLC 140807475 manufacture

Revised: 07/2011 Dolgencorp, inc

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2023. All Rights Reserved.