Package Label.Principal Display Panel
Label
Label (0h)
Bio-relief H
FDA Label NDC 81376-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ssg Ventures Inc for the product Bio-relief H (NDC 81376-004). 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 package label.principal display panel, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Menthol 10%.
Purpose: Topical Analgesic
Otc - Purpose
COOLING GEL W 10% MENTHOL IN ARNICA TINCTURE
Indications & Usage
FOR ARTHRITIS, SPRAINS, SORE MUSCLES, BRUISES, & BACK PAIN
FAST ACTING COOLING PAIN RELIEF
Warnings
FOR EXTERNAL USE ONLY
FLAMMABLE, KEEP AWAY FROM FLAME
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY
Dosage & Administration
Adults & children 2 yrs of age and older: Apply to affected area not more than 4 times daily in one direction not circular. Children under 2 years of age, consult a physician. Massage not necessary. Shake well before use.
Inactive Ingredient
Aloe Vera Oil, Arnica Flower Tincture, Boswellia Powder, Camphor, Frankincense Oil, Green Tea, Hydroxypropyl Cellulose NF, Isopropyl Alcohol, Lavender Oil, Propylene Glycol, Tea Tree Oil, Thymol, Vitamin E.
Other Safety Information
Store in a cool and dry place with lid closed tightly.
* Please review the disclaimer below.
