Label: BENZOCAINE AND RESORCINOL cream
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Contains inactivated NDC Code(s)
NDC Code(s): 55910-185-03 - Packager: Dolgencorp, inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 1, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
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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- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BENZOCAINE AND RESORCINOL
benzocaine and resorcinol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-185 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 200 mg in 1 g RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL 20 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-185-03 28 g in 1 TUBE 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 Business Operations Pharma Pac, LLC 140807475 manufacture
