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Re-leve footlube pain relief - Medication Information

Product NDC Code 61577-5042
Drug Name

Re-leve footlube pain relief

Type Brand
Active Ingredients
Menthol .03 g/g
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 259150
Application Number part348
Labeler Name SOMBRA COSMETICS INC.
Packages
Package NDC Code Description
61577-5042-5 118 g in 1 tube (61577-5042-5)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Menthol USP 3%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions Apply before putting on socks and shoes.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Purified water, Carbomer, Yellow #5 Colorant, Blue #1 Colorant, Hamamelis Viriniana Leaf Extract, Yucca Schidigera Stem/Root Extract, Citrus Grandis (Grapefruit) Seed Extract, Decyl Glucoside, Vegetable Glycerin, Aloe Barbadensis Leaf Juice, Emu Oil, Simmondsia Chinensis (Jojoba) Seed oil, Phenoxyethanol, Germanium oil, Caprylyl Glycol, Sodium Carbonate.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses Detoxifies joints, relieves sore feet, athletes foot, foot odor, perspiration and coldness. Soothes and relieves pain after long hours of standing on feet.

Purpose

Information about the drug product’s indications for use.
Purpose Purpose External Analgesic

Spl product data elements

Usually a list of ingredients in a drug product.
RE-LEVE FOOTLUBE PAIN RELIEF MENTHOL WATER CARBOMER COPOLYMER TYPE A FD&C BLUE NO. 1 FD&C YELLOW NO. 5 WITCH HAZEL YUCCA SCHIDIGERA STEM GRAPEFRUIT SEED OIL DECYL GLUCOSIDE GLYCERIN ALOE VERA LEAF EMU OIL JOJOBA OIL PHENOXYETHANOL GERANIUM OIL, ALGERIAN TYPE CAPRYLYL GLYCOL MENTHOL MENTHOL

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
label LABEL

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of the reach of children ​Keep out of the reach of children

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or Comments? Call Toll Free: 1-866-673-5383, 6070 S. Eastern Ave. Suite 210, Las Vegas, NV 89119, www.reskincare.com

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings Keep out of the reach of children. For external use only. Aviod contact with eyes and mucous membranes, wounds or damaged skin. Store at room temperature. Do not use with heating pads. If symtoms do not respond within one week, see doctor. ReLEVE Products makes no medical claims.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API