FDA.reportPublic FDA data

ICE QUAKE Analgesic Cream White

Manufacturer
Southern Sales & Service, Inc. | GADAL Laboratories, Inc
Effective date
2009-10-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:03:42

Label at a glance#

ProductICE QUAKE Analgesic Cream White
Active ingredientMETHYL SALICYLATE, MENTHOL
Label structure10 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints due to: arthritis simple backache bruises strains sprains

Dosage and administration

Adults and Children 12 Years of Age or Older Apply generously to affected area Massage into painfil area until thoroughly absorbed into skin Repeat as necessary, but no more than 3 to 4 times daily

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 8%

Menthol 2%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints due to:

  • arthritis
  • simple backache
  • bruises
  • strains
  • sprains

Warnings

WARNINGS SECTION

For external use only.

If pregnant or breast-feeding, ask a health professional before use.

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • Avoid contact with eyes and mucous membranes
  • do not bandage tightly or use with a heating devices
  • do not apply to wounds or damaged skin
  • Do not apply to irritated skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • redness is present
  • irritation develops

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 Immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and Children 12 Years of Age or Older

  • Apply generously to affected area
  • Massage into painfil area until thoroughly absorbed into skin
  • Repeat as necessary, but no more than 3 to 4 times daily

INACTIVE INGREDIENT SECTION

Mineral oil, Propylene glycol, Cetyl stearyl alcohol, Purified water, Ceteareth-6, Stearyl alcohol, PEG-20 Cetyl/Stearyl Ether, Methylparaben, propylparaben.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Analgesic Cream White

MENTHOL 2%, METHYL SALICYLATE 8%

NET WT 2 OZ (60 g)

Store: At Room Temperature 15° - 30°C (59°- 86°F). Close cap tightly after use.

ICE QUAKE WHITEICE QUAKE WHITE


Distribute By: SSS group, LLC

Pembroke Pines, FL 33332

Questions or Commnets?

Call 800.213.9370

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1438766methyl salicylate 8 % / menthol 2 % Topical CreamPSN4
1438766menthol 20 MG/ML / methyl salicylate 80 MG/ML Topical CreamSCD4
1438766methyl salicylate 8 % / menthol 2 % Topical CreamSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69822-300-022022-01-28C16284748780-19d75b9d0-33b2-f424-e053-dadaa90a57ceICE QUAKE Analgesic Cream White(Methyl Salicylate and Menthol)
69822-300-022020-02-11C16284748780-19d75b9d0-33b2-f424-e053-dadaa90a57ceICE QUAKE Analgesic Cream White(Methyl Salicylate and Menthol)
69822-300-022020-01-31C16284748780-19d75b9d0-33b2-f424-e053-dadaa90a57ceICE QUAKE Analgesic Cream White(Methyl Salicylate and Menthol)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69822-300-02ICE QUAKE Analgesic Cream White1 in 1 TUBECREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69822-300ICE QUAKE ANALGESIC CREAM WHITE (METHYL SALICYLATE AND MENTHOL) CREAM [SOUTHERN SALES & SERVICE, INC.]4Legacy NDC, 1 package rows20200212_8d5c9bd0-8753-478c-b838-bbc67bafe14a.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69822-30069822-300-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
MENTHOLL7T10EIP3AACTIB
MINERAL OILT5L8T28FGPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
WATER059QF0KO0RIACT
CETEARETH-62RJS3559D3IACT
STEARYL ALCOHOL2KR89I4H1YIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0108de01-bdbb-4e4f-902f-5dc56afb008b8d5c9bd0-8753-478c-b838-bbc67bafe14a2009-10-30WarningsExact identifier
spl id: 0108de01-bdbb-4e4f-902f-5dc56afb008b
spl set id: 8d5c9bd0-8753-478c-b838-bbc67bafe14a

Reported adverse events (FAERS/openFDA)#

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