Re-leve Gel
FDA Label NDC 61577-3242

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sombra Cosmetics Inc. for the product Re-leve (NDC 61577-3242). 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, purpose, keep out of reach of children, uses, warnings, directions, inactive ingredients, questions or comments?  orders:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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