Otc - Active Ingredient
Active Ingredient : Menthol 2.0 %
Miracle Of Aloe Rub Roll On
FDA Label NDC 66391-0046
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Winning Solutions for the product Miracle Of Aloe Rub Roll On (NDC 66391-0046). 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 otc - active ingredient, otc - purpose, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, indications & usage, 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
Purpose : External Analgesic
Warnings
Warnings : For external use only
Otc - Keep Out Of Reach Of Children
Keep Out of Reach of Children : In case of accidental ingestion , get medical help or contact a Position Control center right away.
Dosage & Administration
Directions : adults and children 3 years and older ; apply to affected area no more than 3 to 4 times daily under 3 years: ask a doctor
Inactive Ingredient
Inactive Ingredients : water , isopropyl alcohol , aloe barbadensis leaf juice , hydroxyethylcellulose , chamomilla recutita (matricaria) flower , eucalyptus globulus leaf oil , polysorbate 80 , fragrance , methylparaben , dmdm hydantoin
Indications & Usage
Uses : Temporarily relieves minor aches and pains of muscles and joints due to * arthritis * simple backache * strains * sprains
Package Label.Principal Display Panel
* Please review the disclaimer below.
