FDA.reportPublic FDA data

Nopiate Topical Pain Relief Cream

Manufacturer
Ezra Laboratories, Llc
Effective date
2017-02-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:20:10

Label at a glance#

ProductNopiate Topical Pain Relief
Active ingredientMENTHOL, CAPSAICIN
Label structure7 sections

Dosage and administration

Adults and children 2 years of age and older: Apply to the affected area no more than 3 to 4 times daily. Children under 2 years of age: Consult a physician.

Label contents#

Full prescribing information#

Active ingredients:

OTC - ACTIVE INGREDIENT SECTION

Menthol 5.00%

Capsaicin 0.0275%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Indications:

INDICATIONS & USAGE SECTION

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

Warnings:

WARNINGS SECTION

  • For external use only.
  • Avoid contact with eyes.
  • If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, consult physician.

Do not apply

OTC - DO NOT USE SECTION

  • to wounds or damaged skin.
  • Do not bandage tightly.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

contact physician prior to use.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Apply to the affected area no more than 3 to 4 times daily.
  • Children under 2 years of age: Consult a physician.

Additional Information:

SPL UNCLASSIFIED SECTION

Store at room temperature.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana (Arnica) Flower Extract, Boswellia Serrata, Emu oil, Ethylhexylglycerin, Glycerin, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, SD-Alcohol 40B, Triethanolamine.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130816957011613GTIN-13: 0816957011613
EAN-13: 0816957011613
GTIN-12: 816957011613
UPC-A: 816957011613
GTIN storage (14 digits): 00816957011613		label.jpg

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70745-74970745-749-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
EMU OIL344821WD61IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
TROLAMINE9O3K93S3TKIACT
MENTHOLL7T10EIP3AACTIB
CAPSAICINS07O44R1ZMACTIB

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
0749468a-c47e-21be-e063-6294a90a35e5613882a4-c078-4811-bd72-96c17a8d6a5c2023-10-09WarningsExact identifier
spl set id: 613882a4-c078-4811-bd72-96c17a8d6a5c

Reported adverse events (FAERS/openFDA)#

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