Ice Quake Roll On

Manufacturer: Southern Sales & Service, Inc. | GADAL Laboratories, Inc
Effective date: 2017-01-05
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 23:03:41

Label at a glance#

ProductIce Quake Roll On

Active ingredientMENTHOL, CAMPHOR (NATURAL)

Label structure11 sections

Indications and uses

For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains.

Contacts and useful links#

PhoneLabel contact1 800.213.9370

Websitewww.icequakeonline.com

www.icequakeonline.com

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients	Purpose
Menthol 3.5%	Topical Analgesic
Camphor 0.2%	Topical Analgesic

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Carbomer, Propylene Glycol, Methylparaben, Isopropyl Alcohol, Triethanolamine, FD&C Blue #1, Purified Water.

KEEP THIS AND ALL MEDICINE OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental ingestion, seek professional help and contact a Poison
Control Center inmediately.

WARNINGS

WARNINGS SECTION

For the external use only. Use only as directed.

Avoid contact with eyes.
Do not use with other topical products.
Do not use with heating device.
Do not apply to open wounds or damaged skin.

Stop Use

OTC - STOP USE SECTION

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

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older.

Apply to painful muscles and joints.
Gently massage thoroughly into affected area.
Repeat as necessary but no more than 4 times daily

PURPOSE

OTC - PURPOSE SECTION

Topical Analgesic

Other Information:

SPL UNCLASSIFIED SECTION

Store at room temperaturewith cap closed tightly.

Distribute by:

SSS Group, LLC.

Pembroke Pines, FL 33332

www.icequakeonline.com

Questions or Comments?

OTC - QUESTIONS SECTION

1 800.213.9370

Ice Quake Roll On

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
416207	camphor 0.2 % / menthol 3.5 % Topical Gel	PSN	4
416207	camphor 0.002 MG/MG / menthol 0.035 MG/MG Topical Gel	SCD	4
416207	camphor 0.2 % / menthol 3.5 % Topical Gel	SY	4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69822-102-03	2022-01-28	C162847	48780-1	9d75b9d0-6070-f424-e053-dadaa90a57ce	Gadaderm Frocen Ice FastmPain Releive
69822-102-03	2020-02-11	C162847	48780-1	9d75b9d0-6070-f424-e053-dadaa90a57ce	Gadaderm Frocen Ice FastmPain Releive
69822-102-03	2020-01-31	C162847	48780-1	9d75b9d0-6070-f424-e053-dadaa90a57ce	Gadaderm Frocen Ice FastmPain Releive

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69822-102-03	Ice Quake Roll On	89 mL in 1 BOTTLE, WITH APPLICATOR	GEL	89		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69822-102	ICE QUAKE ROLL ON (MENTHOL CAMPHOR (NATURAL)) GEL [SOUTHERN SALES & SERVICE, INC.]	4	Legacy NDC, 1 package rows	20200212_2a5972bd-07ec-4f2e-9842-cfac1f8183b3.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Ice Quake Roll On
MENTHOL CAMPHOR (NATURAL)
MENTHOL
CAMPHOR (NATURAL)
CARBOXYPOLYMETHYLENE
PROPYLENE GLYCOL
METHYLPARABEN
ISOPROPYL ALCOHOL
TROLAMINE
FD&C BLUE NO. 1
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69822-102	69822-102-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
MENTHOL	L7T10EIP3A	ACTIB
CAMPHOR (NATURAL)	N20HL7Q941	ACTIB
CARBOXYPOLYMETHYLENE	0A5MM307FC	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
TROLAMINE	9O3K93S3TK	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

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
235b275f-9557-4914-9041-ea5299e7fe9b			2a5972bd-07ec-4f2e-9842-cfac1f8183b3	2017-01-05	Warnings	Exact identifier spl id: 235b275f-9557-4914-9041-ea5299e7fe9b spl set id: 2a5972bd-07ec-4f2e-9842-cfac1f8183b3

Reported adverse events (FAERS/openFDA)#

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