BENZOCAINE and RESORCINOL

Manufacturer: Pharma Pac, LLC
Effective date: 2011-02-16
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-05-31 22:28:39

Label at a glance#

ProductBENZOCAINE and RESORCINOL

Active ingredientBENZOCAINE, RESORCINOL

Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Use temporarily relieves itching

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

Use temporarily relieves itching

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

WARNINGS SECTION

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 SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BENZOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67868-117-90	2019-10-29	C162847	48780-1	960f7f55-c551-8e05-e053-dbdaa90a074a	drug facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67868-117-90	BENZOCAINE and RESORCINOL	28 g in 1 TUBE	CREAM	28		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67868-117	BENZOCAINE AND RESORCINOL CREAM [PHARMA PAC, LLC]	7	Legacy NDC, 1 package rows	20110719_6cf1ab7b-8d16-4d41-a3bb-92ba603d3f7e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	7
RESORCINOL	ACTIVE INGREDIENT	YUL4LO94HK	7
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	7
RESORCINOL	ACTIVE MOIETY	YUL4LO94HK	7
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	7
ALPHA-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	7
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	7
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	7
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	7
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	7
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	7
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	7
ISOPROPYL STEARATE	INACTIVE INGREDIENT	43253ZW1MZ	7
LANOLIN ALCOHOLS	INACTIVE INGREDIENT	884C3FA9HE	7
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	7
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	7
POLYOXYL 100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	7
SODIUM SULFITE	INACTIVE INGREDIENT	VTK01UQK3G	7
TRISODIUM HEDTA	INACTIVE INGREDIENT	K3E0U7O8KI	7
VITAMIN A	INACTIVE INGREDIENT	81G40H8B0T	7
VITAMIN D	INACTIVE INGREDIENT	9VU1KI44GP	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	7

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

BENZOCAINE and RESORCINOL
BENZOCAINE
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
RESORCINOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67868-117	67868-117-90

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
BENZOCAINE	U3RSY48JW5	ACTIB
WATER	059QF0KO0R	IACT
CARBOMER HOMOPOLYMER TYPE C	4Q93RCW27E	IACT
CETYL ALCOHOL	936JST6JCN	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
ISOPROPYL PALMITATE	8CRQ2TH63M	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
ISOPROPYL STEARATE	43253ZW1MZ	IACT
LANOLIN ALCOHOLS	884C3FA9HE	IACT
MINERAL OIL	T5L8T28FGP	IACT
POLYOXYL 100 STEARATE	YD01N1999R	IACT
VITAMIN A	81G40H8B0T	IACT
VITAMIN D	9VU1KI44GP	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
SODIUM SULFITE	VTK01UQK3G	IACT
ALPHA-TOCOPHEROL	H4N855PNZ1	IACT
TRISODIUM HEDTA	K3E0U7O8KI	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
CORN OIL	8470G57WFM	IACT
RESORCINOL	YUL4LO94HK	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 314 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / VAGINAL		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 21 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAMUSCULAR	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
ALPHA-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 10 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
CORN OIL	CORN OIL	8470G57WFM	TABLET, DELAYED RELEASE / ORAL	0.03 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	CREAM / TOPICAL		65000 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRA-ARTICULAR	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL, METERED / TOPICAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, EXTENDED RELEASE / ORAL		132 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL		2772 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
SODIUM SULFITE	SODIUM SULFITE	VTK01UQK3G	INJECTION / INTRAVENOUS		96 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / OPHTHALMIC	1.5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IRRIGATION	2 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	GRANULE, FOR SUSPENSION / ORAL		4 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAMUSCULAR		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM SULFITE	SODIUM SULFITE	VTK01UQK3G	CAPSULE / ORAL	0.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / TOPICAL	47.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	EMULSION / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM SULFITE	SODIUM SULFITE	VTK01UQK3G	INJECTION, SOLUTION / INTRA-ARTICULAR		2 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUPPOSITORY / VAGINAL	252 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION/ DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
ISOPROPYL PALMITATE	ISOPROPYL PALMITATE	8CRQ2TH63M	AEROSOL, SPRAY / TOPICAL		397 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	FILM / TRANSDERMAL	58.08 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
ALPHA-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	TABLET, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
ALPHA-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.64 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / TOPICAL		85 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET / ORAL	1.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL, METERED / TRANSDERMAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	OINTMENT, AUGMENTED / TOPICAL		23 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	LOTION / TOPICAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
LANOLIN ALCOHOLS	LANOLIN ALCOHOLS	884C3FA9HE	LOTION / TOPICAL		9360 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SOAP / TOPICAL	0.82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
ALPHA-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	TABLET, CHEWABLE / ORAL	0.1 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL, METERED / TRANSDERMAL		50 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CONCENTRATE / ORAL		12 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAVENOUS		16624 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
LANOLIN ALCOHOLS	LANOLIN ALCOHOLS	884C3FA9HE	CREAM / TOPICAL	6 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SUSPENSION / AURICULAR (OTIC)	0.02 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM SULFITE	SODIUM SULFITE	VTK01UQK3G	INJECTION / INTRAMUSCULAR		96 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY, METERED / NASAL		240 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
d1f9eabc-99ec-4daa-a999-47aaca7d1aa0			6cf1ab7b-8d16-4d41-a3bb-92ba603d3f7e	2011-02-16	Warnings	Exact identifier spl id: d1f9eabc-99ec-4daa-a999-47aaca7d1aa0 spl set id: 6cf1ab7b-8d16-4d41-a3bb-92ba603d3f7e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.