FDA.reportPublic FDA data

Ice Quake

Manufacturer
Southern Sales & Service, Inc.
Effective date
2023-11-29
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:03:00

Label at a glance#

ProductIce Quake
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

For temporary relief of minor pain associated with: arthritis simple backache strains sprains bruises

Dosage and administration

apply to affected area not more than 3 to 4 tmes daily. Adults and children 18 years of age and older: consult a doctor. Children under 18 years of age:

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 15%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor pain associated with:

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

Warnings

WARNINGS SECTION

 Avoid contact with eyes. For external use only.

When using this product

OTC - WHEN USING SECTION

  • do not bandage tightly 
  • do not apply to wounds or damaged skin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of the 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

apply to affected area not more than 3 to 4 tmes daily. Adults and children 18 years of age and older:

consult a doctor. Children under 18 years of age:

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerine, FD&C blue no. 1, carbopol, hydroxypropyl methylcellulose, isopropyl alcohol, propylene glycol, methylparaben, sodium hydroxide, purified water.

IceQuake Pain Relieving Gel 113g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IceQuake Pain Relieving Gel 4 oz 113gIceQuake Pain Relieving Gel 4 oz 113g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1311523menthol 15 % Topical GelPSN8
1311523menthol 0.15 MG/MG Topical GelSCD8
1311523menthol 15 % Topical GelSY8

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69822-100-042022-08-25C16284748780-19d75b9d0-4207-f424-e053-dadaa90a57ceIceQuake Pain Relieving
69822-100-042022-01-28C16284748780-19d75b9d0-4207-f424-e053-dadaa90a57ceIceQuake Pain Relieving
69822-100-042020-02-11C16284748780-19d75b9d0-4207-f424-e053-dadaa90a57ceIceQuake Pain Relieving
69822-100-042020-01-31C16284748780-19d75b9d0-4207-f424-e053-dadaa90a57ceIceQuake Pain Relieving

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69822-100-04Ice Quake113 g in 1 JARGEL1138

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69822-100ICE QUAKE (MENTHOL) GEL [SOUTHERN SALES & SERVICE, INC.]8Current NDC, Legacy NDC, 1 package rows20231201_7a05832f-49ac-4013-b240-4405501e45cd.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69822-10069822-100-04

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
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
ISOPROPYL ALCOHOLND2M416302IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
METHYLPARABENA2I8C7HI9TIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB

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
Ice QuakeMENTHOLSouthern Sales & Service, Inc.7a05832f-49ac-4013-b240-4405501e45cd2023-11-29WarningsExact identifier
ndc (package): 69822-100-04
ndc (product): 69822-100
ndc11 (package): 69822010004
spl id: 0b57cdd0-d6ef-4e06-e063-6294a90a5af5
spl set id: 7a05832f-49ac-4013-b240-4405501e45cd

Reported adverse events (FAERS/openFDA)#

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