Comfortcaine

Manufacturer: QS Key West Aloe, LLC | Southeast Holdings Corp
Effective date: 2025-11-11
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 01:43:20

Label at a glance#

ProductComfortcaine

Active ingredientLIDOCAINE HYDROCHLORIDE

Label structure10 sections

Indications and uses

• For the temporary relief of pain associated with minor burns, sunburn, scrapes, or minor skin irritations.

Dosage and administration

• Adults and children 2 years of age or older: Apply to affected area not more than 3 or 4 times daily. Children under 2 years of age: consult a physician.

Contacts and useful links#

PhoneLabel contact1-800-445-2563

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride (4% w/w)

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

• For the temporary relief of pain associated with minor burns, sunburn, scrapes, or minor skin irritations.

Warnings

WARNINGS SECTION

• For external use only.

• Avoid contact with the eyes.

• Do not use in large quantities, particularly over raw surfaces or blistered areas.

• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• If accidentally ingested contact a physician or Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 2 years of age or older: Apply to affected area not more than 3 or 4 times daily. Children under 2 years of age: consult a physician.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Water, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Sodium Hydroxide, Disodium EDTA, Caprylyl Glycol, Yellow No 5, FD&C Blue No 1.

Other Information

OTHER SAFETY INFORMATION

• Store at room temperature 15-30°C (59-86°F)

Questions or comments?

OTC - QUESTIONS SECTION

1-800-445-2563

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Die CutFront LabelBack Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1592290	Comfortcaine 4 % Topical Gel	PSN	7
1291672	lidocaine 4 % Topical Gel	PSN	7
1592290	lidocaine 0.04 MG/MG Topical Gel [Comfortcaine]	SBD	7
1291672	lidocaine 0.04 MG/MG Topical Gel	SCD	7
1592290	Comfortcaine 0.04 MG/MG Topical Gel	SY	7
1592290	Comfortcaine 4 % Topical Gel	SY	7
1291672	lidocaine 4 % Topical Gel	SY	7

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65008-005-04	Comfortcaine	113 g in 1 BOTTLE, PLASTIC	GEL	113		7
65008-005-04	Comfortcaine	1 in 1 CARTON	GEL	1		7

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Comfortcaine
Lidocaine HCL
ALOE VERA LEAF
WATER
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
EDETATE DISODIUM
SODIUM HYDROXIDE
CAPRYLYL GLYCOL
PHENOXYETHANOL
FD&C YELLOW NO. 5
FD&C BLUE NO. 1
LIDOCAINE HYDROCHLORIDE
LIDOCAINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65008-005	65008-005-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALOE VERA LEAF	ZY81Z83H0X	IACT
WATER	059QF0KO0R	IACT
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	132584PQMO	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
CAPRYLYL GLYCOL	00YIU5438U	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
LIDOCAINE HYDROCHLORIDE	V13007Z41A	ACTIR

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
5	2024-11-22	full-release	2026-06-01 00:38:55

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
Comfortcaine	LIDOCAINE HCL	QS Key West Aloe, LLC	831b7c11-e437-4e74-808e-c9c1eb8b82f6	2025-11-11	Warnings	Exact identifier ndc (package): 65008-005-04 ndc (product): 65008-005 ndc11 (package): 65008000504 spl id: 4354972c-d9c9-cd90-e063-6294a90ad4c5 spl set id: 831b7c11-e437-4e74-808e-c9c1eb8b82f6

Reported adverse events (FAERS/openFDA)#

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