AVEDANA PAIN RELIEVING ROLL ON- menthol gel

Avedana Pain Relieving Roll On by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients

Active ingredients                                                                       Purpose
Camphor 0.4%....................................................................Counter-Irritant
Natural Menthol USP 3.5%....................................................Topical Analgesic

Purpose

Active ingredients                                                                       Purpose
Camphor 0.4%....................................................................Counter-Irritant
Natural Menthol USP 3.5%....................................................Topical Analgesic

Uses

Soothing temporary relief from minor aches and pains associated with sore muscles, strains, joint discomfort, arthritis and tendinitis.

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.  -Do not bandage or use with a heating pad or device, ointments, creams, sprays or liniments.

-Wash hands with cool water after using.

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.

Directions

-Adults/Children 2 years and older: Roll on the affected area up to 4 times daily.

-Children under 2 years of age: Consult a physician.

Inactive Ingredients:

Inactive Ingredients: Amino Methyl Propanol, Arnica montana, Boswellia serrata Extract, Carbomer, FD&C Blue #1, Glycerin USP, Ilex paraguariensis Extract, Isopropyl Alcohol USP, Propylene Glycol USP, Methyl Paraben, Purified Water, Zeodent

Directions

-Adults/Children 2 years and older: Roll on the affected area up to 4 times daily.
-Children under 2 years of age: Consult a physician.

Product Label

INGREDIENTS AND APPEARANCE

AVEDANA PAIN RELIEVING ROLL ON 
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43749-310
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3.5 g  in 100 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	40.04948 g  in 100 g
CARBOMER 940 (UNII: 4Q93RCW27E)	.4 g  in 100 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	.3 g  in 100 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	.00052 g  in 100 g
ISOPROPYL ALCOHOL (UNII: ND2M416302)	46 g  in 100 g
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)	.1 g  in 100 g
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)	.35 g  in 100 g
ARNICA MONTANA (UNII: O80TY208ZW)	.1 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	2.5 g  in 100 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	6 g  in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T)	.15 g  in 100 g
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	.15 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: 43749-310-03	82 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(43749-310)