FDA.reportPublic FDA data

AMORAY Analgesic Gel

Manufacturer
MY IMPORTS USA LLC
Effective date
2019-05-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:59:24

Label at a glance#

ProductAMORAY Analgesic Gel
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC)
Label structure11 sections

Indications and uses

for temporary relief of minor aches and pains in muscles and joints associated with: simple backaches, strains sprains sports injuries arthritis bruises

Dosage and administration

clean affected area before applying product adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.25 %

Camphor 0.5%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

  • for temporary relief of minor aches and pains in muscles and joints associated with:
  • simple backaches,
  • strains
  • sprains
  • sports injuries
  • arthritis
  • bruises

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY

Do not use:

  • with other topical pain relievers
  • with heating pads or heating devices

When using this product

OTC - WHEN USING SECTION

  • do not use in or near eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
  • redness or irritation develops

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

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

  • clean affected area before applying product
  • adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Carbomer, FD&C Blue No.1, Methyl Paraben Sodium, Methyl Salicylate, Propylene Glycol, Propyl Paraben Sodium, Sodium hydroxide, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY & DRUG FACT PANELPRINCIPAL DISPLAY & DRUG FACT PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2167138camphor 0.5 % / menthol 1.25 % Topical GelPSN2
2167138camphor 0.005 MG/MG / menthol 0.0125 MG/MG Topical GelSCD2
2167138camphor 0.5 % / menthol 1.25 % Topical GelSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130088168666412GTIN-13: 0088168666412
EAN-13: 0088168666412
GTIN-12: 088168666412
UPC-A: 088168666412
GTIN storage (14 digits): 00088168666412		AMY_IceColdGel8oz_FIN_OL (1).jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51628-3021-22021-01-29C16284748780-1ba0f9c33-26ad-a910-e053-dadaa90a0b85AMORAY Ice Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51628-3021-2AMORAY Analgesic Gel227 g in 1 JARGEL2272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51628-3021AMORAY ANALGESIC GEL (MENTHOL) GEL [MY IMPORTS USA LLC]2Legacy NDC, 1 package rows20190504_87ea2462-731d-06c8-e053-2a95a90a108a.zip

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
51628-302151628-3021-2

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
METHYLPARABEN SODIUMCR6K9C2NHKIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
PROPYLPARABEN SODIUM625NNB0G9NIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
METHYL SALICYLATELAV5U5022YIACT
MENTHOLL7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB

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
87fff6bf-7330-7bf2-e053-2a95a90a9ad187ea2462-731d-06c8-e053-2a95a90a108a2019-05-03WarningsExact identifier
spl id: 87fff6bf-7330-7bf2-e053-2a95a90a9ad1
spl set id: 87ea2462-731d-06c8-e053-2a95a90a108a

Reported adverse events (FAERS/openFDA)#

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