Ice Quake

Manufacturer: Gadal Laboratories, Inc.
Effective date: 2012-09-04
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:33:03

Label at a glance#

ProductIce Quake

Active ingredientMenthol

Label structure9 sections

Indications and uses

temporarily relieves minor pain associated with: arthritis simple backache muscle strains sprains bruises cramps

Dosage and administration

adults and children over 18 years: apply to affected area squeeze desired amount of ICEQUAKE onto affected area massage dispensed gel into painful area until thoroughly absorbed repeat as necessary, but no more than 3 to 4 times daily. IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 15%

PURPOSE

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with:

arthritis
simple backache
muscle strains
sprains
bruises
cramps

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product

use only as directed
do not bandage tightly or use with a heating pad
avoid contact with eyes or mucous membranes
do not apply to wounds or damaged, broken or irritated skin
if severe burning sensation occurs, discontinue use immediately
do not expose the area treated with product to heat or direct sunlight.

OTC - STOP USE SECTION

Stop use and ask a doctor if:

condition worsens
redness is present
irritation develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children over 18 years:

apply to affected area
squeeze desired amount of ICEQUAKE onto affected area
massage dispensed gel into painful area until thoroughly absorbed
repeat as necessary, but no more than 3 to 4 times daily.

IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

Inactive Ingredients

INACTIVE INGREDIENT SECTION

HPMC, Glycerine, FD&C blue #1, Carbopol, Isopropyl alcohol, Propylene glycol, Methylparaben, Sodium hydroxide, Purified water.

SPL UNCLASSIFIED SECTION

MANUFACTURED BY:
GADAL Laboratories, Inc.• Miami, FL 33186

PRINCIPAL DISPLAY PANEL - 113 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ICEQUAKE
Pain Relieving GEL
Menthol
15%

Net wt 4 oz (113 g)

Principal Display Panel - 113 g Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1311523	menthol 15 % Topical Gel	PSN	1
1311523	menthol 0.15 MG/MG Topical Gel	SCD	1
1311523	menthol 15 % Topical Gel	SY	1

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
53113-100-01	2019-11-13	C162847	48780-1	97449f38-c731-f6ea-e053-dbdaa90aa703	Ice Quake

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53113-100-01	Ice Quake	113 g in 1 TUBE	GEL	113		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53113-100	ICE QUAKE (MENTHOL) GEL [GADAL LABORATORIES, INC.]	1	Legacy NDC, 1 package rows	20120919_1de1c714-cc53-45dc-a678-b36e59b15184.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	1
Menthol	ACTIVE MOIETY	L7T10EIP3A	1
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked)	INACTIVE INGREDIENT	4Q93RCW27E	1
FD&C Blue NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	1
Isopropyl Alcohol	INACTIVE INGREDIENT	ND2M416302	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

Ice Quake
Menthol
HYPROMELLOSES
Glycerin
FD&C Blue NO. 1
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked)
Sodium Hydroxide
Water
Propylene Glycol
Methylparaben
Isopropyl Alcohol

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53113-100	53113-100-01

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
Menthol	L7T10EIP3A	ACTIB
HYPROMELLOSES	3NXW29V3WO	IACT
Glycerin	PDC6A3C0OX	IACT
FD&C Blue NO. 1	H3R47K3TBD	IACT
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked)	4Q93RCW27E	IACT
Sodium Hydroxide	55X04QC32I	IACT
Water	059QF0KO0R	IACT
Propylene Glycol	6DC9Q167V3	IACT
Methylparaben	A2I8C7HI9T	IACT
Isopropyl Alcohol	ND2M416302	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 9 · 491 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	FILM, SOLUBLE / ORAL		11 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, ORALLY DISINTEGRATING / ORAL		41 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
FD&C Blue NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	CAPSULE, LIQUID FILLED / ORAL	0.08 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / URETHRAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
FD&C Blue NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	PASTE, DENTIFRICE / DENTAL	NA		Exact identifier — unii candidate 37 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	INSERT / VAGINAL	54.21 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	POWDER, FOR SUSPENSION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CONCENTRATE / ORAL		12 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked)	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	OINTMENT, AUGMENTED / TOPICAL		23 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / RESPIRATORY (INHALATION)	25 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / ORAL		9120 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	GEL / TOPICAL		70 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRAVENOUS		95 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked)	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	EMULSION / TOPICAL		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAMUSCULAR	176 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	OINTMENT, AUGMENTED / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	CREAM / VAGINAL	0.19 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
FD&C Blue NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	TABLET, COATED / ORAL	0.52 mg		Exact identifier — unii candidate 37 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	TAMPON / VAGINAL	62.1 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
FD&C Blue NO. 1	FD&C BLUE NO. 1	H3R47K3TBD	POWDER, FOR SUSPENSION / ORAL	1 mg/5ml		Exact identifier — unii candidate 37 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRACAUDAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	JELLY / TOPICAL	NA		Exact identifier — unii candidate 27 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	CAPSULE, DELAYED RELEASE / ORAL		105 mg	Exact identifier — unii candidate 27 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
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / NASAL	20 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SWAB / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SUBMUCOSAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRADERMAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	EMULSION / ORAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / VAGINAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 174 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	PASTE, DENTIFRICE / DENTAL	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 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	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / IONTOPHORESIS	168.1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	7.01 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	NA		Exact identifier — unii candidate 174 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAOCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / NASAL	26 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 174 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
a6f37e88-1493-4c23-8f17-3136964406ca			1de1c714-cc53-45dc-a678-b36e59b15184	2012-09-04	Warnings	Exact identifier spl id: a6f37e88-1493-4c23-8f17-3136964406ca spl set id: 1de1c714-cc53-45dc-a678-b36e59b15184

Reported adverse events (FAERS/openFDA)#

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