Active Ingredients
Menthol 9.6%
Pain Be Gone Cream
FDA Label NDC 82721-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Back To Earth Inc. for the product Pain Be Gone (NDC 82721-001). 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 ingredients, otc - purpose, warnings, dosage & administration, indications & usage, inactive ingredient, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Pain Relieving Gel
Warnings
■ For external use only.
■ Avoid Contact with the eyes. If conditions worsen, or if symptoms
persist for more that 7 days or clear up and occur again within a few
days, discontinue use of this product and consult a physician/doctor.
■ Do not apply to wounds or damaged skin.
■ Do not bandage tightly.
■ Keep out of reach of children. In case of overdose, get medical help
or contact a Poison Control Center right away.
Dosage & Administration
■ 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 Physician/Doctor
Indications & Usage
■ For the temporary relief of minor aches and pains of muscles and joints
associated with simple backache, arthritis, strains, bruises, and sprains.
For penetrating pain relief.
Inactive Ingredient
Purified Water, Caprylhydroxamic Acid, Glyceryl caprylate, Glycerin,
Mentha Arvensis (Peppermint) Oil, Arnica (Arnica Montana) Macerated Oil
Rosmarinus Officinalis (Rosemary) Oil, Citrus Limonum (Lemon) Organic Oil,
Eucalyptus Globulus (Eucalyptus) Oil, Gaultheria Procumbens
(Wintergreen) Oil, Cinnamomum Camphora (White) Oil,
Pinus Sylvestris (Scotch Pine) Oil, Sodium Carbomer, Polysorbate 80.
Otc - Keep Out Of Reach Of Children
■ Keep out of reach of children. In case of overdose, get medical help
or contact a Poison Control Center right away.
Package Label.Principal Display Panel
* Please review the disclaimer below.
