FDA.reportPublic FDA data

PainShield cream

Manufacturer
Nutranext LLC | Accupack Midwest
Effective date
2019-03-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:26:15

Label at a glance#

ProductPainShield
Active ingredientMENTHOL
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Menthol USP 3.7%

OTC - PURPOSE SECTION

Purpose

Topical analgesic

INDICATIONS & USAGE SECTION

Uses temporarily relieves minor aches and pains of muscles and joints due to

  • arthritis
  • simple backaches
  • strains
  • bruises
  • sprains

WARNINGS SECTION

Warnings

For external use only Flammable: Keep away from fire or flame.

OTC - DO NOT USE SECTION

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • with other ointments, creams, sprays or liniments

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes
  • do not bandage tightly
  • wash hands with cool water after use

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens or rash or irritation develops
  • symptoms last more than 7 days
  • condition clears up and occurs again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

adults and children 12 years of age and older: apply and massage onto affected area no more than 3 to 4 times daily
children under 12 years of age: ask a doctor

OTHER SAFETY INFORMATION

Other information

  • close cap tightly
  • store in a cool, dry place

INACTIVE INGREDIENT SECTION

Inactive ingredients Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Carbomer, Dimethyl Sulfone(MSM), EDTA, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Melaleuca Altemifolia (Tea Tree) Leaf Oil, Pyridoxine HCl (Vitamins B6), Phenoxyethanol & Methyl/Ethyl/Butyl/Propyl/Isobutylparabens, Polysorbate 20, Purified Water, Tocopheryl (Vitamin E) Acetate, Triethanolamine

SPL UNCLASSIFIED SECTION

Manufactured and Distributed by Stop Aging Now as Nutranext Direct, LLC

1301 Sawgrass Corporate Parkway, Sunrise, FL 33323 • 800-627-9721

NDC# 72914-0001-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PainShield™

Advanced Pain Relief Cream for Arthritis, Joint, Muscle and Back Pain

Cooling Menthol

Net Wt. 6 oz. (170 grams)

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72914-0001-12024-12-18C16284748780-1f386c649-a0f4-0266-e053-dadaa90a7c1aPainShield cream
72914-0001-12023-01-30C16284748780-1f386c649-a0f4-0266-e053-dadaa90a7c1aPainShield cream

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72914-000172914-0001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ISOPROPYL ALCOHOLND2M416302IACT
2-(2-(2-(2-PHENOXYETHOXY)ETHOXY)ETHOXY)ETHANOLY050HYR4XAIACT
WATER059QF0KO0RIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
PROPYLPARABENZ8IX2SC1OHIACT
POLYSORBATE 207T1F30V5YHIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
TROLAMINE9O3K93S3TKIACT
ISOBUTYLPARABEN0QQJ25X58GIACT
MENTHOLL7T10EIP3AACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
EDETATE DISODIUM7FLD91C86KIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
METHYLPARABENA2I8C7HI9TIACT
ETHYLPARABEN14255EXE39IACT
BUTYLPARABEN3QPI1U3FV8IACT

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
2992b34e-7bf3-4a3f-e063-6294a90ad62f84273eda-1233-ae04-e053-2a91aa0a99d02024-12-18WarningsExact identifier
spl set id: 84273eda-1233-ae04-e053-2a91aa0a99d0

Reported adverse events (FAERS/openFDA)#

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