Active Ingredients
Lidocaine Hydrochloride 4%, Menthol 1%
Cbdaf
FDA Label NDC 58443-0366
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Prime Enterprises for the product Cbdaf (NDC 58443-0366). 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, do not use, when using this product, stop use and ask doctor if, kepp out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses
Use for temporary relief of minor pain
Warnings
For external use only.
Do Not Use
On large areas of the body or on cut, irritated or swollen skin
On puncture wounds
For more than one week without consulting a doctor
When Using This Product
Use only as directed
Avoid contact with eyes and mucous membranes
Do not apply to skin folds
Do not apply to wounds or damaged, broken or irritated skin
Do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
Stop Use And Ask Doctor If
condition worses
irriation develops
redness appears
symptoms persist for more than 7 days or clear up and occurs again within a few days
Kepp Out Of Reach Of Children
If product is swallowed, get medical help or contact a Poison Control Center right away.
If Pregnant Or Breast-Feeding
ask a health professional before use.
Directions
Adults and children over 12 years:
apply a thin layer to affected area every 6 to 8 hours, but no more than 3 to 4 times daily
if product comes in contact hands, wash hands with soap and water
children 12 years or younger: ask a doctor
Inactive Ingredients
Acrylamide/Sodium Acrylate Copolymer, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Arnica Montana Flower Extract, Borago Officinalis Seed Oil, Boswellia Serrata Extract, Camellia Oleifera (Green Tea) Leaf Extract, Cannabidiol, Chamomilla Recutita (Matricaria) Flower Extract, Curcuma Longa (Turmeric) Root Extract, Glycerin, Harpagophytum Procumbens Root Extract, Mentha Piperita (Peppermint) Oil, Mineral Oil, Oenothera Biennis (Evening Primrose) Oil, Polysorbate 20, Propylene Glycol, Ribes Nigrum (Black Currant) Fruit Extract, Salix Alba (White Willow) Bark Extract, SD Alcohol 40-B, Sodium Hydroxide, Trideceth-6, Water
Questions And Comments
480.562.6282
Cbdaf Cbd & Lidocaine Topical Gel
Principal Display Label (58443 0366 3)
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