AMORAY ANALGESIC GEL- menthol gel 
MY IMPORTS USA LLC

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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AMORAY Ice Gel

Active Ingredients

Menthol 1.25 %

Camphor 0.5%

Purpose

Topical Analgesic

Uses:

Warnings

FOR EXTERNAL USE ONLY

Do not use:

When using this product

Stop use and ask a doctor if

If pregnant or breastfeeding

ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

If swallowed get Medical Help or contact a Poison Control Center right away

Directions

Inactive Ingredients

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

PRINCIPAL DISPLAY & DRUG FACT PANEL

AMORAY ANALGESIC GEL 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51628-3021
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51628-3021-2227 g in 1 JAR; Type 0: Not a Combination Product04/08/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34104/08/2019
Labeler - MY IMPORTS USA LLC (195767988)

Revised: 5/2019
Document Id: 87fff6bf-7330-7bf2-e053-2a95a90a9ad1
Set id: 87ea2462-731d-06c8-e053-2a95a90a108a
Version: 2
Effective Time: 20190503
 
MY IMPORTS USA LLC