FDA.reportPublic FDA data

Paingone Freeze 5

Manufacturer
QUALITY HEALTH INNOVATIONS LIMITED
Effective date
2023-11-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:19:42

Label at a glance#

ProductPaingone Freeze 5
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

Temporary pain relief associated with sprains, strains, backache, arthritis, aching muscles and joints.

Dosage and administration

Adults and children 2 years and older : Apply a small amount to the affected area and massage gently, no more than 4 times per day. Wash hands with cool water after use. Children under 2 years of age : Consult a doctor.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol   5%

Purpose

OTC - PURPOSE SECTION

Cooling pain relief

Uses

INDICATIONS & USAGE SECTION

Temporary pain relief associated with sprains, strains, backache, arthritis, aching muscles and joints.

Warnings

WARNINGS SECTION

For external use only.

Flammable: Keep away from open flame or excessive heat.

Ask a doctor before useif you are: pregnant or breastfeeding, suffering from a skin condition.


When using this product: Avoid contact with the eyes or mucous membranes. Do not apply to wounds or inflamed or broken skin. Cease use if a rash or irritation occurs. Do not use with other topical treatments. Do not use under bandages or occlusive dressings


Stop use and ask a doctor if: Condition worsens, Symptoms persist for more than 7 days, Symptoms clear up and recur within a few days


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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and older: Apply a small amount to the affected area and massage gently, no more than 4 times per day. Wash hands with cool water after use. Children under 2 years of age: Consult a doctor.

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Water, Aloe Barbadensis Leaf Juice, SD Alcohol 40B, Arnica Montana (Arnica) Flower Extract, Propylene Glycol, Acrylates/C10-30 alkyl Acrylate Crosspolymer, Pyridoxine HCL Crystalline (B6), Methylsulfonylmethane (MSM), Aminomethyl, Propanol, FD&C Blue #1

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80223-002-012024-01-30C16284748780-11030e365-347b-111a-e063-dadaa90a10e2Paingone - Freeze

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80223-00280223-002-01

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
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALCOHOL3K9958V90MIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
MENTHOLL7T10EIP3AACTIB

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
14ac2b43-6b49-5532-e063-6294a90a69d40b1ff981-bf22-4d12-8484-c5fa3b1a40002024-03-27WarningsExact identifier
spl set id: 0b1ff981-bf22-4d12-8484-c5fa3b1a4000

Reported adverse events (FAERS/openFDA)#

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