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Premieres pain - Medication Information

Product NDC Code 32472-102
Drug Name

Premieres pain

Type Brand
Active Ingredients
Menthol 7 g/100ml
Route TOPICAL
Dosage Form SPRAY
RxCUI drug identifier 1086713
Application Number part348
Labeler Name Premiere Enterprises
Packages
Package NDC Code Description
32472-102-01 29.5 ml in 1 bottle (32472-102-01)
32472-102-03 88 ml in 1 bottle (32472-102-03)
32472-102-04 118 ml in 1 bottle (32472-102-04)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients USP Menthol 7%

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: For adults and children 2 years of age and older: Shake well and apply to affected area not more than 3-4 times daily. Get extra relief by using after warm shower or bath. Will not stain clothing. For children under 2 years of age, consult a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients: Water, Isopropyl Alcohol, Glycerol, Eucalyptus Leaf Oil, Wintergreen Leaf Oil, Peppermint Oil, Coconut Oil. Manufactured for: PREMIERE ENTERPRISES, Los Angeles, CA 90034 800-576-7616 / www.Amazing-Solutions.com

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: Temporary relief of minor aches & pains of muscles and joints.

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
Premieres Pain menthol menthol menthol water isopropyl alcohol glycerin eucalyptus oil methyl salicylate peppermint oil coconut oil

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.
Principal Display Panel - Bottle Label NDC# 32472-102-01 PREMIER'S PAIN SPRAY ™ A Miracle in Every Bottle! Temporary Relief of Minor Aches & Pains • ARTHRITIS • SORE MUSCLES • BACKACHE • SPRAINS • STIFF JOINTS • MUSCLE CRAMPS Net 1 fluid oz./29.5 ml. NATURAL MENTHOL • HERBAL FORMULA Principal Display Panel - Bottle Label

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
PREMIERE'S PAIN SPRAY Premiere Enterprises, Inc. Pain Spray Drug Facts Other Information: Store at room temperature.

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates, including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.

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 reach of children- if swallowed get medical help or contact a poison center right away. Avoid contact with eyes Do not apply to open wounds or damaged skin Do not bandage tightly

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: For external use only Flammable. Keep away from flame. Keep out of reach of children- if swallowed get medical help or contact a poison center right away. Avoid contact with eyes Do not apply to open wounds or damaged skin Do not bandage tightly Consult a doctor if excessive skin irritation occurs, or if you are prone to allergic reactions to salicylates, including aspirin. If condition worsens, if symptoms persist for more than 7 days or clear up and recur again within a few days, discontinue use of this product and consult a doctor.

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