Active Incredient
Menthol, 3.0%
Trurelief Rubiton Rub It Where It Hurts
FDA Label NDC 58133-451
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Specialty Labs, Inc. for the product Trurelief Rubiton Rub It Where It Hurts (NDC 58133-451). 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 incredient, purpose, uses, warnings, otc - when using, otc - stop use, otc - 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
Topical analgesic
Uses
temporarily relieves minor pain associated with: • arthritis • simple backache • muscle strains • sprains • bruises • cramps
Warnings
for external use only
Otc - When Using
When using this prodcut•use only as directed •do not bandage tightly or use with heating pad •avoid contact with eyes or mucous membranes •do not apply to wounds or damaged skin
Otc - Stop Use
Stop use and ask a doctor if• condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • irritation develops
Otc - Keep Out Of Reach Of Children
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
Directions:
Adults and children over 12 years:• apply generously to affected area • massage into painful area until thoroughly absorbed into skin • repeat as necessary, but no more than 4 time daily
Children 12 years or younger: ask a doctor
Recent Major Changes
typographical correction and effective date update
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Anthemis nobilis (Roman Chamomile), Arnica montana Flower Extract, Butylene Glycol, Calendula officinalis (Marigold), Caprylyl Glycol, Capsicum frutescens Fruit, Carbomer, Centaurea cyanus (Cornflower), Cetearyl Alcohol, Chamomilla recutita (Matricaria Chamomilla), Coriandrum sativum (Coriander) Fruit Oil, Emu Oil, Fragrance, Hamamelis virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Hypericum perforatum (St. John's Wort), Methylsulfonylmethane, Phenoxyethanol, Purified Water, Salix alba (Willow) Bark Extract, SD Alcohol 40, Sorbitol, Tetrasodium EDTA, Tilia cordata (Lime Tree), Triethanolamine.
* Please review the disclaimer below.
