BENZOCAINE AND RESORCINOL cream

BENZOCAINE and RESORCINOL by

Drug Labeling and Warnings

BENZOCAINE and RESORCINOL by is a Otc medication manufactured, distributed, or labeled by Pharma Pac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                      Purpose
Benzocaine 20%....................External Analgesic
Resorcinol 3%........................External Analgesic

PURPOSE

Use temporarily relieves itching

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Use temporarily relieves itching

Other information - store at 20 degrees - 25 degrees C (68 degrees - 77 degrees F)

WARNINGS

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

DOSAGE & ADMINISTRATION

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 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

INGREDIENTS AND APPEARANCE

BENZOCAINE AND RESORCINOL 
benzocaine and resorcinol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67868-117
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: 67868-117-90	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 - Pharma Pac, LLC (140807475)

Registrant - Pharma Pac, LLC (140807475)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Pac, LLC		140807475	manufacture