Active Ingredient
Menthol USP 8.0%
Protec Roll-on
FDA Label NDC 68678-067
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ach Ventures Corp for the product Protec Roll-on (NDC 68678-067). 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 ingredient, purpose, uses, warnings:, when using this product: use only as directed, stop use and ask doctor if:, if pregnant or breast feeding:, keep 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
Pain Reliever
Uses
Temporary relieves minor aches and pains associated with
•sore muscles and joints
•arthritis
•backache
•muscle strains
•sprains
•bruises
Warnings:
For external use only
When Using This Product: Use Only As Directed
•Do not bandage or use a heating pd or device
•Avoid contact with eyes and mucous membranes
•Do not apply to open wounds or damaged skin
•Do not use with other ointments, creams, sprays, liniments
•After applying wash hands thoroughly with cool water
Stop Use And Ask Doctor If:
•condition worsens or symptoms persist for more than 7 days or clear up and recur
•Redness is present or irritation develops
If Pregnant Or Breast Feeding:
Ask a health professional before use
Keep Out Of Reach Of Children
In case of accidental ingestion get medical help or contact a Poison Control Center Immediately
Directions
Adults and children 2 years of age and older: Roll directly onto affected area without the need to rub, massage or bandage. Repeat as necessary but do not apply more the 4 times daily
Children under 2 years of age: Consult a Physician
Other Information
Store in cool dry place with lid or cap closed tightly
Flammable: Keep away from excessive heat or open flame
Inactive Ingredients
Ilex Paraguariensis Leaf Extract, Arnica, Boswellia Serrata, Eucalyptus Oil, Peppermint Oil, Hyaluronic Acid, Yucca Extract, Nitric Oxide, Dimethyl Sulfone, SD Alcohol 39 C, Purified Water, Glycerin, Acrylates, Triethanolamine
* Please review the disclaimer below.
