FDA Label for Avedana Pain Relieving Roll On

View Indications, Usage & Precautions

Avedana Pain Relieving Roll On Product Label

The following document was submitted to the FDA by the labeler of this product Unipack Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.

-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


Product Label




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