AVEDANA PAIN RELIEF- menthol spray 
Unipack LLC

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Avedana ® Pain Relief Spray

Active ingredients

Active ingredients                                                                         Purpose
Natural Menthol USP 9%....................................................Topical Analgesic

Purpose

Active ingredients                                                                       Purpose
Natural Menthol USP 9%....................................................Topical Analgesic

Directions

Directions: Spray to completely cover painful area.  Get extra relief by using after warm shower or bath.  Reapply as needed.

Warnings

For external use only.

Flammable

Keep away from excessive heat or open flames.

Ask a doctor before using if you

Ask a doctor before using if you: have sensitive skin, are pregnant or are breast feeding.

When using this product:

When using this product: 

-Avoid contact with eyes and mucous membranes.

-Do not apply to wounds, damaged or irritated skin, or if excessive irritation develops.

Stop use and ask a doctor if:

Stop use and ask a doctor if: condition worsens, symptoms persist more than 7 days, or clear up and reoccur.

Keep out of reach of children:

Keep out of reach of children: If ingested, seek medical help and contact poison control center immediately.

Other information

Store in a cool, dry place with spray cap screwed tightly.

Inactive Ingredients:

Inactive Ingredients: Arnica montana, Boswellia serrata Extract, Camphor USP, Coconut Oil, Eucalyptus globulus Leaf Oil, Ilex paraguariensis Extract, Isopropyl Alcohol USP, Lavender Oil, Methyl salicylate, Peppermint Oil, Propylene Glycol USP, and Purified Water

Directions

Directions: Spray to completely cover painful area. Get extra relief by using after warm shower or bath. Reapply as needed.

Avedana ® Pain Relieving Spray

Made with All - Natural Botanical Ingrdeints.

Label

AVEDANA PAIN RELIEF 
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43749-510
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL9 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
COCONUT OIL (UNII: Q9L0O73W7L)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
ARNICA MONTANA (UNII: O80TY208ZW)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
WATER (UNII: 059QF0KO0R)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
Product Characteristics
Colorwhite (Clear) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43749-510-04118 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product09/17/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01709/29/2014
Labeler - Unipack LLC (009248480)
Registrant - Unipack LLC (116015769)
Establishment
NameAddressID/FEIBusiness Operations
Unipack LLC009248480manufacture(43749-510)

Revised: 1/2024
Document Id: 0e23c0a8-e981-27e1-e063-6394a90ae5db
Set id: e29e722a-2ee9-4ec8-90f0-2910e482495c
Version: 10
Effective Time: 20240104
 
Unipack LLC