The following Structured Product Label (SPL) was submitted to the FDA by Unipack Llc for the product Avedana Pain Relieving Roll On (NDC 43749-310). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, flammable, ask a doctor before using if you, when using this product:, stop use and ask a doctor if:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients Purpose
Camphor 0.4%....................................................................Counter-Irritant
Natural Menthol USP 3.5%....................................................Topical Analgesic
Active ingredients Purpose
Camphor 0.4%....................................................................Counter-Irritant
Natural Menthol USP 3.5%....................................................Topical Analgesic
Soothing temporary relief from minor aches and pains associated with sore muscles, strains, joint discomfort, arthritis and tendinitis.
For external use only.
Keep away from excessive heat or open flames.
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: condition worsens, symptoms persist more than 7 days, or clear up and reoccur.
Keep out of reach of children: If ingested, seek medical help and contact poison control center immediately.
-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: 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 (Label)
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