FDA.reportPublic FDA data

Ice Quake

Manufacturer
Southern Sales & Service, Inc. | GADAL Laboratories, Inc
Effective date
2017-01-05
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:03:43

Label at a glance#

ProductIce Quake Plus
Active ingredientMENTHOL, METHYL SALICYLATE, CAMPHOR (SYNTHETIC)
Label structure11 sections

Indications and uses

temporarily relieves minor pain associated with Arthritis Smple backache Strains Bruises Pprains Cramps

Dosage and administration

adults and children over 18 years and older: Apply to affected area Squeeze desired amount of IceQuake Plus onto affected area massage dispensed cream into painful area until thoroughly absorbed Repeat as necessary, but no more than 3 to 4 times daily

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients               Purpose

Methyl Salicylate  10%      Topical Analgesic

Menthol 10%                    Topical Analgesic

Camphor 3.1%                 Topical Analgesic

OTC - PURPOSE SECTION

Purpose

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with

  • Arthritis
  • Smple backache
  • Strains
  • Bruises
  • Pprains
  • Cramps

Warnings

WARNINGS SECTION

For external use only

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • redness is present
  • irritation develops

When using this product:

OTC - WHEN USING SECTION

  • Use only as directed
  • Do not bandage tightly
  • Do not use with a heating devices
  • Avoid contact with the eyes and mucous membranes
  • Do not apply to wounds, 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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children over 18 years and older:
  • Apply to affected area
  • Squeeze desired amount of IceQuake Plus onto affected area
  • massage dispensed cream into painful area until thoroughly absorbed
  • Repeat as necessary, but no more than 3 to 4 times daily

INACTIVE INGREDIENT SECTION

Inactive ingredients: HPMC, glycerin, FD&C Blue No.1, carbopol, isopropyl alcohol, propylene glycol, methylparaben, sodium hydroxide, water

DISTRIBUTE BY:

OTC - QUESTIONS SECTION

SSS Group, LLC Pembroke Pines, Fl 33332

Questions or Comments?

Call 1 800.213.9370

ICE QUAKE PLUS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1990885camphor 3.1 % / menthol 10 % / methyl salicylate 10 % Topical CreamPSN5
1990890Ice Quake 3.1 % / 10 % / 10 % Topical CreamPSN5
1990890camphor 31 MG/ML / menthol 100 MG/ML / methyl salicylate 100 MG/ML Topical Cream [Ice Quake]SBD5
1990885camphor 31 MG/ML / menthol 100 MG/ML / methyl salicylate 100 MG/ML Topical CreamSCD5
1990885camphor 3.1 % / menthol 10 % / methyl salicylate 10 % Topical CreamSY5
1990890Ice Quake (camphor 3.1 % / menthol 10 % / methyl salicylate 10 % ) Topical CreamSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69822-101-042022-01-28C16284748780-19d75b9cf-eb04-f424-e053-dadaa90a57cede8a4938-3646-44cc-8640-8b13b33abd6d
69822-101-042020-02-11C16284748780-19d75b9cf-eb04-f424-e053-dadaa90a57cede8a4938-3646-44cc-8640-8b13b33abd6d
69822-101-042020-01-31C16284748780-19d75b9cf-eb04-f424-e053-dadaa90a57cede8a4938-3646-44cc-8640-8b13b33abd6d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69822-101-04Ice QuakePlus113 g in 1 TUBECREAM1135

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69822-101ICE QUAKE PLUS (METHYL SALICYLATE, MENTHOL, CAMPHOR) CREAM [SOUTHERN SALES & SERVICE, INC.]5Legacy NDC, 1 package rows20200212_de8a4938-3646-44cc-8640-8b13b33abd6d.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69822-10169822-101-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
HYPROMELLOSE 2910 (10000 MPA.S)0HO1H52958IACT
GLYCERINPDC6A3C0OXIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)F68VH75CJCIACT
ISOPROPYL ALCOHOLND2M416302IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
METHYLPARABENA2I8C7HI9TIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ff67173e-53e6-496c-9530-02279bf926c5de8a4938-3646-44cc-8640-8b13b33abd6d2017-01-05WarningsExact identifier
spl id: ff67173e-53e6-496c-9530-02279bf926c5
spl set id: de8a4938-3646-44cc-8640-8b13b33abd6d

Reported adverse events (FAERS/openFDA)#

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