AVEDANA COOL HOT ICE- menthol gel 
Unipack, Inc.

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 Ingredient

Active Ingredients                                                      Purpose

Menthol 2%..................................................External Pain Reliever

Purpose

External Pain Reliever

Uses

Temporarily relief of minor pains of muscles and joints associated with - simple back ache - arthritis - sprains, strains, or bruises

Warnings

Warnings

For external use only.  Avoid contact with eyes

Do not use

Do not use - internally - with heating pad or devices - on wounds or damaged skin

Ask a doctor before use

Ask doctor before use if you have sensitive skin

When using this product

When using this product - Use only as directed - do not bandage tightly - avoid contact with eyes and mucus membranes

If pregnant or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children.  In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

-Adult and children 2 years of age and older.  Clean skin thoroughly.  Apply liberally to affected area no more than 3-4 times daily.  No protective cover needed.

-May be used with ice packs

-May be used with wet or dry bandages, but wrap loosely

-Children under 2 years of age, consult a doctor

Other information

Other information store between 59o - 86oF (15o - 30oC)

Keep tightly closed

Do not use, pour, spill, or store near heat or open flame

Other ingredients

Camphor, Carbomer 940, FDC Blue #1, Isopropyl alcohol, Propylene glycol, Purified water, Sodium hydroxide

Product Label

Product LabelProduct Label

AVEDANA COOL HOT ICE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43749-321
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43749-321-08227 g in 1 JAR; Type 0: Not a Combination Product11/04/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/04/2017
Labeler - Unipack, Inc. (009248480)
Establishment
NameAddressID/FEIBusiness Operations
Unipack, Inc.009248480manufacture(43749-321)

Revised: 5/2018
Document Id: 1850af06-be68-45cd-a107-604506bef374
Set id: 619c8e3f-0cad-4eb1-8dbb-632f3db74ba3
Version: 2
Effective Time: 20180501
 
Unipack, Inc.