FDA Label for Re-leve

View Indications, Usage & Precautions

Re-leve Product Label

The following document was submitted to the FDA by the labeler of this product Sombra Cosmetics. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredients



Menthol USP 4%


Purpose



Purpose
External Analgesic


Keep Out Of Reach Of Children



Keep out of reach of children


Uses



Temporarily relieves minor aches and pains of muscles and joints associated with: simple backaches, strains, bruises, and sprains


Warnings



Keep out of reach of children.  For external use only. Avoid contact with eyes and mucous membranes, wounds or damaged skin.  Do not use with heating pads.

Stop uses and ask a doctor if: Conditions worsen, symptoms persist for more than 7 days, symptoms clear up and occur again within a few days.


Directions



Adult and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub until gel is absorbed, children under 2 years of age: consult your doctor.


Inactive Ingredients



aloe barbadensis leaf juice, carbomer, decyl glucoside, water, citrus grandis (grapefruit) seed extract, emu oil, citrus aurantium dulcis (orange) peel oil, glycerin, hamamelis virginiana (witch hazel) leaf extract, yucca schidigera root extract, sodium hydroxymethylglycinate


Questions Or Comments?  Orders:



Call toll-free:  1-844-303-0037, 155 NE Court St.-152, Prineville, OR, 97754.  www.allforu.org.  Alcohol-free product made in USA.


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