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Pain crush - Medication Information

Product NDC Code 69676-0004
Drug Name

Pain crush

Type Brand
Active Ingredients
Menthol 7 g/100ml
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 311509
Application Number part348
Labeler Name Genexa Inc.
Packages
Package NDC Code Description
69676-0004-6 89 ml in 1 bottle, with applicator (69676-0004-6)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient + 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 shake well before each use adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients organic aloe vera leaf juice, organic ethyl alcohol, organic glycerin, organic licorice root extract, organic peppermint oil, purified water (aqua), xanthan gum

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 temporarily relieves the minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

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.
Pain Crush Menthol MENTHOL MENTHOL ALOE VERA LEAF WATER GLYCERIN XANTHAN GUM ALCOHOL LICORICE PEPPERMINT OIL PEPPERMINT

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.
Genexa® COLD THERAPY PAIN RELIEF ROLL ON PAIN CRUSH™ Menthol / Topical Analgesic 3 FL OZ (89 mL) Back Pain + Arthritis / Sore Muscles + Joints / Shoulder + Leg Pain USDA ORGANIC NON GMO Project VERIFIED FREE OF DYES & PARABENS NDC 69676-0004-6 Pain Crush_label_20190304

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.
Drug Facts +Certified Organic, free of parabens, dyes, petroleum and genetically modified organisms Distributed by: Genexa Inc., Beverly Hills, CA 90211 www.genexa.com Questions? 1-855-GENEXA-1 Certified Organic by SCS Global Services MADE IN THE USA WITH GLOBALLY SOURCED INGREDIENTS

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.
Ask a doctor before use if you have redness over the affected area.

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use on wounds or damaged skin on a child under 12 years of age with arthritis-like conditions

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 Control Center immediately.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days excessive skin irritation occurs

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product avoid contact with eyes or mucous membranes do not bandage tightly or use with a heating pad

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breast-feeding, ask a doctor before use.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store between 20 to 25°C (68 to 77°F) close cap tightly after use see bottom of bottle for Lot No. and Exp. Date.

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 fire or flame.

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