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.
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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

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