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Painaway with natural peppermint and balsam peru - Prescription Drug Labeling

Product NDC Code 70470-1118
Drug Name

Painaway with natural peppermint and balsam peru

Type Brand
Active Ingredients
Menthol 1.3 mg/50mg
Balsam peru oil 1.2 mg/50mg
Route TOPICAL
Dosage Form OIL
RxCUI drug identifier 1747723
Application Number part347
Labeler Name PHYTOPIA CO., LTD.
Packages
Package NDC Code Description
70470-1118-5 50 mg in 1 bottle, dropper (70470-1118-5)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Drug Facts menthol(2.6%) Balsam Peru Oil (2.4%) Analgesic in the treatment of muscle pain

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.
Dosage Suggestion Adults 5ml maximum per day Children 1ml maximum per day

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients EUCALYPTUS RADIATA LEAF OIL, JAVA CITRONELLA OIL, SUNFLOWER OIL, JOJOBA OIL, ROSEMARY OIL, EVENING PRIMROSE OIL, LEMON OIL, LAVENDER OIL

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.
Directions Apply on skin and gentle massage around painful area.

Purpose

Information about the drug product’s indications for use.
Use Helps relieve the condition of pain and stiffness.

Spl product data elements

Usually a list of ingredients in a drug product.
PainAway with natural peppermint and Balsam Peru PainAway MENTHOL MENTHOL BALSAM PERU OIL BALSAM PERU OIL LEMON OIL EVENING PRIMROSE OIL LAVENDER OIL JAVA CITRONELLA OIL SUNFLOWER OIL JOJOBA OIL ROSEMARY OIL EUCALYPTUS RADIATA LEAF OIL GAULTHERIA PROCUMBENS LEAF Violet Miron Bottle

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.
PainAway-With natural Peppermint and Balsam Peru Oil PainAway

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.
Warnings For external use only. Stop use and ask doctor if rash occurs. Keep out reach of children.

Storage and handling

Information about safe storage and handling of the drug product.
Other Information Protect this product from excessive heat and direct sun.

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. Stop use and ask doctor if rash occurs. Keep out reach of children.

Disclaimer: Do not rely on openFDA 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