FDA.reportPublic FDA data

PARACTIN QuantumActiv Pain Relief Cream

Manufacturer
NHR SCIENCE CORP
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:04

Label at a glance#

ProductPARACTIN QuantumActiv Pain Relief Cream
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains.

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.5%

Purpose:

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings:

WARNINGS SECTION

For external use only

Do Not Use:

OTC - DO NOT USE SECTION

On damaged or broken skin.

When using this product:

OTC - WHEN USING SECTION

  • Avoid contact with the eyes.
  • Do not bandage tightly.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • Rash or irritation develops and lasts.
  • Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

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.

If pregnant or breast-feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: consult a doctor.

Other information:

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aloe Extract, Andrographis Paniculata Extract, Arnica Montana Flower Extract, Beeswax, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Cinnamomum Cassia (Cinnamon) Oil, Helianthus Annuus (Sunflower) Oil, Mangifera Indica (Mango) Butter, Moringa Oleifera Oil, Ricinus communis (Castor) Oil, Simmondsia Chinensis (Jojoba) Oil, Tocopheryl Acetate (Vitamin E).

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1045482menthol 1.5 % Topical CreamPSN2
1045482menthol 15 MG/ML Topical CreamSCD2
1045482menthol 1.5 % Topical CreamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83224-372-00PARACTIN QuantumActiv Pain Relief Cream59.15 mL in 1 JARCREAM59.152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83224-372PARACTIN QUANTUMACTIV PAIN RELIEF CREAM (MENTHOL) CREAM [NHR SCIENCE CORP]2Current NDC, 1 package rows20231106_ae2f89cf-120c-4c6f-9e81-4560e6fa0373.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
83224-37283224-372-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOEV5VD430YW9IACT
ANDROGRAPHIS PANICULATA WHOLE0P49L952WZIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
YELLOW WAX2ZA36H0S2VIACT
SHEA BUTTERK49155WL9YIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CHINESE CINNAMON OILA4WO0626T5IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
MANGOI629I3NR86IACT
CASTOR OILD5340Y2I9GIACT
JOJOBA OIL724GKU717MIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
PARACTIN QuantumActiv Pain Relief CreamMENTHOLNHR SCIENCE CORPae2f89cf-120c-4c6f-9e81-4560e6fa03732023-11-06WarningsExact identifier
ndc (package): 83224-372-00
ndc (product): 83224-372
ndc11 (package): 83224037200
spl id: 0976e636-18bd-0818-e063-6294a90adeb8
spl set id: ae2f89cf-120c-4c6f-9e81-4560e6fa0373

Reported adverse events (FAERS/openFDA)#

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