FDA.reportPublic FDA data

amoray premium Vaporizing Inhaler

Manufacturer
Ningbo Pulisi Daily Chemical Products Co.,Ltd.
Effective date
2016-03-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:35

Label at a glance#

Productamoray premium Vaporizing Inhaler
Active ingredientCAMPHOR (NATURAL)
Label structure9 sections

Dosage and administration

THE PRODUCT DELIVERS IN EACH 800ML OF AIR 0.04 TO 0.150 MG OF LEVMETAMFETAMINE. Do not use more often than 2 hours. ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER: 2 INHALATIONS IN EACH NOSTRIL. CHILDREN 6 TO 12 YEARS OF AGE (WITH ADULT SUPERVISION): 1 INHALATION IN EACH NOSTRIL. CHILDREN UNDER 6 YEARS OF AGE: CONSULT A DOCTOR. Childre nuder 2 years of age: DO NOT USE.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 50% ................... Nasal Decongestant

camphor 13% .................. Nasal Decongestant

Purpose

OTC - PURPOSE SECTION

Nasal Decongestant

INDICATIONS:

INDICATIONS & USAGE SECTION

USE FOR TEMPORARY RELIEF OF NASAL CONGESTION DUE TO:

The COMMON COLD, HAY FEVER OR UPPER RESPIRATORY ALLERGIES.

Warnings:

WARNINGS SECTION

When using this product

  • DO NOT EXCEED RECOMMENDED DOSAGE.
  • Temporary BURNING, STINGING, SNEEZING, OR AN INCREASED IN NASAL DISCHARGE may occur.
  • THE USE OF THIS CONTAINER BY MORE THAN ONE PERSON MAY SPREAD INFECTION.
  • DO NOT USE THIS PRODUCT FOR MORE THAN 7 DAY. USE ONLY AS DISRECTED.
  • FREQUENT OR PROLONGED USE MAY CAUSE NASAL CONGESTION TO RECUR OR WORSEN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. if swallowed, get medical help or contact a Poision Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

  • THE PRODUCT DELIVERS IN EACH 800ML OF AIR 0.04 TO 0.150 MG OF LEVMETAMFETAMINE.
  • Do not use more often than 2 hours.

ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER: 2 INHALATIONS IN EACH NOSTRIL.

CHILDREN 6 TO 12 YEARS OF AGE (WITH ADULT SUPERVISION): 1 INHALATION IN EACH NOSTRIL.

CHILDREN UNDER 6 YEARS OF AGE: CONSULT A DOCTOR.

Childre nuder 2 years of age: DO NOT USE.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

BUMYL ACETATE, EUCALYTUS OIL, LAVENDER OIL, MENTHE

OTHER SAFETY INFORMATION

THIS INHALER IS EFFECTIVE FOR A MINIMUM OF 3 MONTHS AFTER FIRST USE. KEEP INHALER TIGHTLY CLOSED AND STORE AT 59-86 F (15-30 C )

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Inhaler labelInhaler label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130088168882706GTIN-13: 0088168882706
EAN-13: 0088168882706
GTIN-12: 088168882706
UPC-A: 088168882706
GTIN storage (14 digits): 00088168882706		amoray premium vaporizing inhaler.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40104-800-012020-01-31C16284748780-19d75b9cf-f323-f424-e053-dadaa90a57ceecb22eaf-4142-471c-95c6-a1b54eca8b7a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40104-800-01amoray premium Vaporizing Inhaler198 in 1 INHALERLIQUID1981

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40104-800AMORAY PREMIUM VAPORIZING INHALER (MENTHOL) LIQUID [NINGBO PULISI DAILY CHEMICAL PRODUCTS CO.,LTD.]1Legacy NDC, 1 package rows20160331_ecb22eaf-4142-471c-95c6-a1b54eca8b7a.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
40104-80040104-800-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AIACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB
EUCALYPTUS OIL2R04ONI662IACT
BORNYL ACETATE213431586XIACT
LAVENDER OILZBP1YXW0H8IACT

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
71607b3f-aac5-4d9f-bc7b-b968f7b1baffecb22eaf-4142-471c-95c6-a1b54eca8b7a2016-03-31WarningsExact identifier
spl id: 71607b3f-aac5-4d9f-bc7b-b968f7b1baff
spl set id: ecb22eaf-4142-471c-95c6-a1b54eca8b7a

Reported adverse events (FAERS/openFDA)#

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