Active Ingredient
Menthol 4%
The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Good Neighbor Roll-on Menthol Pain Relief Gel (NDC 46122-803). 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, stop use and ask a doctor if, if pregnant or breastfeeding, keep out of reach of children and pets, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Menthol 4%
Topical analgesic
Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ muscle strains ■ sprains ■ bruises
For external use only
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
■ condition worsens ■ redness is present ■irritation develops ■ symptoms persist for more than 7 days or clear up and occur again within a few days
ask a health professional before use
If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away.
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 WATER
Children 12 years or younger:■ ask a doctor
Store at room temperature
aloe barbadensis leaf juice, aminomethyl propanol, arctium lappa extract, arnica montana flower extract, boswellia
serrata extract, calendula officinalis flower extract, camellia sinensis leaf extract, camphor, carbomer, FD&C blue no.1, FD&C yellow no.5, glycerin, ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, melissa officinalis leaf extract, methyl methacrylate crosspolymer,
tocopheryl acetate, water
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