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NDC 43749-0310-03 Avedana Pain Relieving Roll On 40; 350 mg/mL; mg/mL Details

Avedana Pain Relieving Roll On 40; 350 mg/mL; mg/mL

Avedana Pain Relieving Roll On is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Unipack LLC. The primary component is CAMPHOR (SYNTHETIC); MENTHOL.

Product Information

NDC	43749-0310
Product ID	43749-310_e362d7b9-9e5e-d240-e053-2a95a90aca72
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Avedana Pain Relieving Roll On
Proprietary Name Suffix	n/a
Non-Proprietary Name	Menthol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	40; 350
Active Ingredient Units	mg/mL; mg/mL
Substance Name	CAMPHOR (SYNTHETIC); MENTHOL
Labeler Name	Unipack LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 43749-0310-03 (43749031003)

Pricing Information	N/A
NDC Package Code	43749-310-03
Billing NDC	43749031003
Package	89 mL in 1 BOTTLE, WITH APPLICATOR (43749-310-03)
Marketing Start Date	2017-09-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 59256eea-2a78-4065-82b7-ac81283c2a3e Details

Active ingredients

Active ingredients Purpose

Camphor 0.4%....................................................................Counter-Irritant

Natural Menthol USP 3.5%....................................................Topical Analgesic

Purpose

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:

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

Avedana ® Pain Relief Roll-On | 3 fl oz. | Bottle with Applicator.

Easy to Use and Apply.
Fast Relief from Pain.
Back on Run like never before.

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	350 mg in 1 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	40 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER 940 (UNII: 4Q93RCW27E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ARNICA MONTANA (UNII: O80TY208ZW)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43749-310-03	89 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	09/17/2017

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

Labeler - Unipack LLC (009248480)

Registrant - Unipack LLC (116015769)

Name	Address	ID/FEI	Business Operations
Establishment
Unipack LLC		009248480	manufacture(43749-310)

Revised: 7/2022

Document Id: e362d7b9-9e5e-d240-e053-2a95a90aca72

Set id: 59256eea-2a78-4065-82b7-ac81283c2a3e

Version: 6

Effective Time: 20220709

Search by Drug Name or NDC

NDC 43749-0310-03 Avedana Pain Relieving Roll On 40; 350 mg/mL; mg/mL Details

Avedana Pain Relieving Roll On 40; 350 mg/mL; mg/mL

Product Information

Package

Package Images

NDC 43749-0310-03 (43749031003)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 59256eea-2a78-4065-82b7-ac81283c2a3e Details

Active ingredients

Purpose

Uses

Warnings

Flammable

Ask a doctor before using if you

When using this product:

Stop use and ask a doctor if:

Keep out of reach of children:

Directions

Inactive Ingredients:

Directions

Product Label

INGREDIENTS AND APPEARANCE

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