Bonicaeasex Colorless Roll-on Menthol Pain Relieving Gel
FDA Label NDC 75568-041
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Planet (anhui) Pharmaceutical Co.,ltd for the product Bonicaeasex Colorless Roll-on Menthol Pain Relieving (NDC 75568-041). 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 drug facts, active ingredient, purpose, uses, when using this product, stop use and ask a doctor if, if pregnant or breast feeding,, keep out of reach of children and pets., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Menthol 4%
Purpose
Topical Analgesic
Uses
Temporarily relieves minor pain associated with: • arthritis • simple backache • muscle strains • sprains • bruises • cramps
When Using This Product
• use only as directed. Read and follow all directions and warnings on this carton • rare cases of serious burns have been reported with products of this type • do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use • avoid contact with eyes and mucous membranes • do not apply to wounds or damaged, broken or irritated skin • a transient burning sensation may occur upon application but generally disappears in several days • if severe burning sensation occurs, discontinue use immediately • do not expose the area treated with product to heat or direct sunlight avoid applying into skin folds
Stop Use And Ask A Doctor If
• condition worsens • redness is present irritation develops • symptoms persist for more than 7 days or clear up and occur again within a few days • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
Flammable • keep away from fire or flame
If Pregnant Or Breast Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children And Pets.
If swallowed, get medical help or contact Poison Control Cente right away.
Directions
Adults and children over 12 years: • apply a thin layer to affected area • massage into painful area until thoroughly absorbed into skin • repeat as necessary, but no more than 3 to 4 times daily IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATERChildren 12 years or younger: • ask a doctor
Inactive Ingredients
• Arnica Oil • Calendula Oil • Carbomer • Dimethyl Isosorbide • Glycerin • Isopropyl Alcohol • Lemon Oil • Triethanolamine • Tea Tree Oil • Water
Questions And Comments?
1-816-716-0852 Monday Friday 9AM-5PM
* Please review the disclaimer below.
