OraLabs Cold Sore Treatment

Manufacturer: OraLabs
Effective date: 2014-09-04
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:40:10

Label at a glance#

ProductOraLabs Cold Sore Treatment

Active ingredientBENZOCAINE

Label structure8 sections

Indications and uses

For treatment of cold sores/fever blisters on the face and lips

Dosage and administration

Clean the affected Adults and children 2 years of age and older: Apply to affected area not more than 4 times daily Children under 2 years of age: consult a physician Rub in gently – Applies clear Wash hands before and after applying cream Do not share this product with anyone

Contacts and useful links#

PhonePoison Help1-800-222-1222

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine

Purpose

OTC - PURPOSE SECTION

Cold Sore/Fever Blister Treatment/Pain Reliever

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Uses

INDICATIONS & USAGE SECTION

For treatment of cold sores/fever blisters on the face and lips

Warnings

WARNINGS SECTION

For external use only: Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a physician.

Allergy Alert: Do not use if you are allergic to any of the ingredients in this product.

When using this product avoid contact with eyes. Use only as directed.

Stop use and ask a doctor if the condition gets worse. Do not use longer than 1 week unless directed by a doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

Clean the affected

Adults and children 2 years of age and older: Apply to affected area not more than 4 times daily

Children under 2 years of age: consult a physician

Rub in gently – Applies clear

Wash hands before and after applying cream

Do not share this product with anyone

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Benzyl Alcohol, Docosanol, Mineral Oil, Propylene Glycol, Sucrose Stearate, Tocopherol, Water.

Package/Label Principal Display Panel

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
63645-162-04	2020-01-31	C162847	48780-1	9d75b9d0-732a-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63645-162-04	OraLabs Cold Sore Treatment	1 g in 1 CONTAINER	OINTMENT	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63645-162	ORALABS COLD SORE TREATMENT (BENZOCAINE) OINTMENT [ORALABS]	1	Legacy NDC, 1 package rows	20140905_792873ae-b15a-408e-92d0-e8bf1e6fc8f1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	1
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	1
DOCOSANOL	INACTIVE INGREDIENT	9G1OE216XY	1
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SUCROSE STEARATE	INACTIVE INGREDIENT	274KW0O50M	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

OraLabs Cold Sore Treatment
Benzocaine
LIGHT MINERAL OIL
DOCOSANOL
BENZYL ALCOHOL
SUCROSE STEARATE
PROPYLENE GLYCOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63645-162	63645-162-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LIGHT MINERAL OIL	N6K5787QVP	IACT
BENZOCAINE	U3RSY48JW5	ACTIB
DOCOSANOL	9G1OE216XY	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
SUCROSE STEARATE	274KW0O50M	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT

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 3 · 156 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED / ORAL	25 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPONGE / TOPICAL	40 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / RESPIRATORY (INHALATION)	25 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	TABLET, FILM COATED / ORAL	2.49 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / TOPICAL		5148 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / INTRAMUSCULAR		500 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM, AUGMENTED / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	CAPSULE, EXTENDED RELEASE / ORAL	1.23 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	TABLET / ORAL	1.06 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
DOCOSANOL	DOCOSANOL	9G1OE216XY	AEROSOL, FOAM / TOPICAL	1.1 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL / TOPICAL	19.2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	OIL / TOPICAL		2509 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	AEROSOL, FOAM / TOPICAL		240 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / AURICULAR (OTIC)	56.55 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
SUCROSE STEARATE	SUCROSE STEARATE	274KW0O50M	TABLET, EXTENDED RELEASE / ORAL		57 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SWAB / TOPICAL	34.6 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SPRAY, METERED / NASAL	5 mg/1ml		Exact identifier — unii candidate 50 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRAVENOUS		1620 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRA-ARTICULAR	1 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYRUP / ORAL		5700 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	OIL / AURICULAR (OTIC)		419 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / RECTAL		3315 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	PASTILLE / ORAL	3.6 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAVENOUS		16624 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / ORAL		360 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / INTRAVENOUS		400 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / OPHTHALMIC	1.5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 50 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	ELIXIR / ORAL		9306 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAMUSCULAR		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / SOFT TISSUE		40 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SUPPOSITORY / RECTAL	129 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	LIQUID / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRASYNOVIAL		18 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
SUCROSE STEARATE	SUCROSE STEARATE	274KW0O50M	CREAM / TOPICAL	5 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
BENZYL ALCOHOL	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / TOPICAL	2 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	63.4 %w/v		Exact identifier — unii candidate 81 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
792873ae-b15a-408e-92d0-e8bf1e6fc8f1			792873ae-b15a-408e-92d0-e8bf1e6fc8f1	2014-09-04	Warnings	Exact identifier spl id: 792873ae-b15a-408e-92d0-e8bf1e6fc8f1 spl set id: 792873ae-b15a-408e-92d0-e8bf1e6fc8f1

Reported adverse events (FAERS/openFDA)#

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