FDA.reportPublic FDA data

SYNC ICE

Manufacturer
iON Pharma, LLC
Effective date
2025-07-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:09:14

Label at a glance#

ProductSYNC ICE
Active ingredientMENTHOL
Label structure11 sections

Indications and uses

Uses: Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains and sprains

Dosage and administration

Directions: Adults and children 12 years of age and older: Rub a thin thin film over not more than 4 times daily mass; massage not necessary Children under 12 years of age: Consult physician

Label contents#

Full prescribing information#

Drug facts Active ingredient

OTC - PURPOSE SECTION

Drug facts
Active ingredient: purpose

Menthol 4% Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Uses: Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains and sprains

Warnings

WARNINGS SECTION

Warnings:

For external use only

Flammable: Keep away from excessive heat or open flame

Ask a doctor before use if you have: Sensitive skin

When using this product

OTC - WHEN USING SECTION

When using this product:

  • Avoid contact with eyes or mucous membranes
  • Do not apply to wounds or damaged skin
  • Do not use with other ointments, creams, sprays or liniments
  • Do no apply to irritated skin or if excessive irritation develops
  • Do not bandage
  • Wash hands after use with cool water
  • Do not use with heating pad or decide
  • Store in a cool dry place

Stop use section

OTC - STOP USE SECTION

Stop use and ask a doctor if:

Condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur

If pregnant or breast-feeding section

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding: Ask a healthcare professional before use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately

Directions section

DOSAGE & ADMINISTRATION SECTION

Directions:

Adults and children 12 years of age and older: Rub a thin
thin film over not more than 4 times daily mass; massage
not necessary

Children under 12 years of age: Consult physician

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Alcohol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Camphor, Carbomer, FD&C Blue No. 1, FD&C Yellow No. 5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water.

Questions comments section

OTC - QUESTIONS SECTION

Questions or Comments:

  • 833.711.8833
  • info@syncrelief.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sync Relief IceSync Relief Ice

Sync Relief Ice LabelSync Relief Ice Label

NDC 82944-300-74

sync RELIEF ICE

Relief in Motion

COLD THERAPY

PAIN RELIEF

PAIN RELIEF GEL

ROLL-ON

PARABEN-FREE

FOR SORE MUSCLES, BACKACHES, SORE JOINTS & ARTHRITIS

2.5 FL. OZ. / 74 ml

www.syncrelief.com

Does not contain NSAIDs, Ibuprofen, Salicylate

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415974menthol 4 % Topical GelPSN2
415974menthol 0.04 MG/MG Topical GelSCD2
415974menthol 4 % Topical GelSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82944-300-74SYNC ICE1 in 1 CARTONGEL12
82944-300-74SYNC ICE74 in 1 BOTTLE, WITH APPLICATORGEL742

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82944-300-74ML - Milliliter82944-300ac7ea20b-01b0-4ff3-ac67-98a50136657812025-08-11

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82944-30082944-300-74

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL 95%7528N5H79BIACT
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
SILICAETJ7Z6XBU4IACT
TRIETHANOLAMINE9O3K93S3TKIACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AACTIB
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
CARBOMER0A5MM307FCIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CAMELLIA SINENSIS LEAFW2ZU1RY8B0IACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
BOSWELLIA CARTERII OIL67ZYA5T02KIACT

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
SYNC ICESYNC RELIEF ICEiON Pharma, LLC38ce98ce-a7bf-8041-e063-6394a90ae7302025-07-28WarningsExact identifier
ndc (package): 82944-300-74
ndc (product): 82944-300
ndc11 (package): 82944030074
spl id: 3b01b609-19ac-bc80-e063-6294a90acad1
spl set id: 38ce98ce-a7bf-8041-e063-6394a90ae730

Reported adverse events (FAERS/openFDA)#

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