Active Ingredient
Menthol 4%
Pain Relieving Gel
FDA Label NDC 11822-8940
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Pain Relieving Gel (NDC 11822-8940). 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, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External analgesic
Uses
for temporary relief from minor aches and pains of muscles & joints associated with
- simple backache
- arthritis
- strains
- bruises
- sprains
Warnings
For external use only
Flammable, keep away from fire or flame.
When Using This Product
- avoid contact with the eyes
- do not apply to wounds or damaged skin
- do not bandage tightly
Stop Use And Ask A Doctor If
condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
- children under 2 years of age: consult a doctor
Other Information
- store in a cool dry place with lid closed tightly
Inactive Ingredients
Aloe barbadensis leaf juice, Arctium lappa root extract, Arnica montana flower extract, blue 1, Boswellia carterii resin extract, Calendula officinalis flower extract, Camellia sinensis leaf extract, camphor, carbomer, Chamomilla recutita (matricaria) flower extract, glycerin, Ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, Juniperus communis fruit extract, Melissa officinalis extract, silica, tocopheryl acetate, triethanolamine, water, yellow 5
Disclaimer
*This product is not manufactured or distributed by Biofreeze Performance Health, distributor of BioFreeze ® Cool the Pain Roll-On Fast Acting Menthol Pain Relief
Adverse Reaction
DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE,
CAMP HILL, PA 17011
www.riteaid.com
Package Label.Principal Display Panel
Compare to the active ingredient of Biogreeze ® Roll-on*
ROLL-ON COOLING PAIN RELIEF
4% MENTHOL
for arthritis, sore muscles, joints & back pain
soothing menthol
diminishing scent
paraben-free
2.5 FL OZ (73 mL)
Mm01 (Mm01)
* Please review the disclaimer below.
