AVEDANA PAIN-RELIEVING- menthol spray

Avedana Pain-Relieving by

Drug Labeling and Warnings

Avedana Pain-Relieving by is a Otc medication manufactured, distributed, or labeled by Unipack, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Product label

INGREDIENTS AND APPEARANCE

AVEDANA PAIN-RELIEVING 
menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43749-510
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	42.591 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)	.2 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662)	.230 g  in 100 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	.00052 g  in 100 g
ISOPROPYL ALCOHOL (UNII: ND2M416302)	42 g  in 100 g
PEPPERMINT OIL (UNII: AV092KU4JH)	.09 g  in 100 g
COCONUT OIL (UNII: Q9L0O73W7L)	.14 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y)	.14 g  in 100 g
ARNICA MONTANA (UNII: O80TY208ZW)	.1 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	5.05 g  in 100 g
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)	.350 g  in 100 g
LAVENDER OIL (UNII: ZBP1YXW0H8)	.009 g  in 100 g
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)	.1 g  in 100 g

Product Characteristics
Color	white (Clear)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43749-510-04	108 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	09/17/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/29/2014

Labeler - Unipack, Inc. (009248480)

Establishment
Name	Address	ID/FEI	Business Operations
Unipack, Inc.		009248480	manufacture(43749-510)