AMORAY PREMIUM VAPORIZING INHALER- menthol liquid 
Ningbo Pulisi Daily Chemical Products Co.,Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients

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

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

Purpose

Nasal Decongestant

INDICATIONS:

USE FOR TEMPORARY RELIEF OF NASAL CONGESTION DUE TO:

The COMMON COLD, HAY FEVER OR UPPER RESPIRATORY ALLERGIES.

Warnings:

When using this product

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:

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:

BUMYL ACETATE, EUCALYTUS OIL, LAVENDER OIL, MENTHE

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 )

Inhaler label

AMORAY PREMIUM VAPORIZING INHALER 
menthol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40104-800
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)13 mg
Inactive Ingredients
Ingredient NameStrength
MENTHOL (UNII: L7T10EIP3A) 50 mg
EUCALYPTUS OIL (UNII: 2R04ONI662)  
BORNYL ACETATE (UNII: 213431586X)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40104-800-01198 in 1 INHALER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/31/2016
Labeler - Ningbo Pulisi Daily Chemical Products Co.,Ltd. (529047265)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Pulisi Daily Chemical Products Co.,Ltd.529047265manufacture(40104-800)

Revised: 3/2016
Document Id: 71607b3f-aac5-4d9f-bc7b-b968f7b1baff
Set id: ecb22eaf-4142-471c-95c6-a1b54eca8b7a
Version: 1
Effective Time: 20160331
 
Ningbo Pulisi Daily Chemical Products Co.,Ltd.