FDA.reportPublic FDA data

Fast Freeze Pain Relieving

Manufacturer
NATURAL ESSENTIALS, INC.
Effective date
2025-08-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:10:50

Label at a glance#

ProductFast Freeze Pain Relieving
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

Temporary relief of minor aches and pains of muscles and joints associated with: Simple backache Arthritis Strains Sprains

Dosage and administration

Adults/Children 2 years and older: Roll on the affected area not more than 3 to 4 times daily Shake well before use Children under 2 years old: Consult a physician.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 3.5%

Purpose

OTC - PURPOSE SECTION

Cooling Pain Relief

Uses

INDICATIONS & USAGE SECTION

Temporary relief of minor aches and pains of muscles and joints associated with:

  • Simple backache
  • Arthritis
  • Strains
  • Sprains

Warnings

WARNINGS SECTION

  • For external use only
  • Flammable
  • Keep away from excessive heat or open flame

Do not use

OTC - DO NOT USE SECTION

  • With heating pad or device
  • With ointments, creams, sprays or liniments
  • On wounds, damaged skin or irritated skin

Ask a doctor before use if you

SPL UNCLASSIFIED SECTION

  • Have sensitive skin
  • Are pregnant or breastfeeding

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes or mucous membranes
  • Do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up then reoccur again within a few days
  • 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults/Children 2 years and older:

  • Roll on the affected area not more than 3 to 4 times daily
  • Shake well before use

Children under 2 years old:Consult a physician.

Other information

OTHER SAFETY INFORMATION

  • Replace cap after use
  • Store in a cool, dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Carbomer, dl-alpha Tocopheryl Acetate, dl-Camphor, Isopropyl Alcohol, Mate (Ilex Paraguariensis) Extract, Methylparaben, Triethanolamine, Water.

Principal Display Panel - 89 mL Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAST FREEZE®

Naturally
Cool
Pain Relieving Roll-On

Helps to relieve

  • Sore muscles
  • Strains & sprains
  • Joint pain
  • Invigorating, cooling menthol
  • Greaseless & stain-free
  • Natural ingredients include
    Vitamin E, Aloe & Ilex

3 oz (89 mL)

Principal Display Panel - 89 mL Container Label
Principal Display Panel - 89 mL Container Label

Principal Display Panel - 120 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAST FREEZE®

Naturally
Cool
Pain Relieving Gel

Helps to relieve

  • Sore muscles
  • Strains & sprains
  • Joint pain
  • Invigorating, cooling menthol
  • Greaseless & stain-free
  • Natural ingredients include
    Vitamin E, Aloe & Ilex

Net wt. 4 oz (113 g)

Principal Display Panel - 120 mL Tube Label
Principal Display Panel - 120 mL Tube Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66902-116-03Fast Freeze Pain Relieving89 mL in 1 CONTAINERGEL894
66902-116-04Fast Freeze Pain Relieving120 mL in 1 TUBEGEL1204
66902-116-36Fast Freeze Pain Relieving89 mL in 1 BOTTLEGEL894
66902-116-36Fast Freeze Pain Relieving12 in 1 CASEGEL124
66902-116-48Fast Freeze Pain Relieving120 mL in 1 TUBEGEL1204
66902-116-48Fast Freeze Pain Relieving12 in 1 CASEGEL124

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
66902-11666902-116-03, 66902-116-04, 66902-116-48, 66902-116-36

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
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ISOPROPYL ALCOHOLND2M416302IACT
METHYLPARABENA2I8C7HI9TIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB

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
Fast Freeze Pain RelievingMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.15a26af1-ca5a-40fc-a411-6c0e8ae18fbb2025-08-18WarningsExact identifier
ndc (package): 66902-116-36
ndc (package): 66902-116-03
ndc (package): 66902-116-04
ndc (package): 66902-116-48
ndc (product): 66902-116
ndc11 (package): 66902011636
ndc11 (package): 66902011648
ndc11 (package): 66902011604
ndc11 (package): 66902011603
spl id: 3ca5d610-63fa-a6f3-e063-6394a90a85b1
spl set id: 15a26af1-ca5a-40fc-a411-6c0e8ae18fbb

Reported adverse events (FAERS/openFDA)#

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