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Serum x - Medication Information

Product NDC Code 82317-001
Drug Name

Serum x

Type Brand
Pharm Class Amide Local Anesthetic [EPC],
Amides [CS],
Antiarrhythmic [EPC],
Local Anesthesia [PE]
Active Ingredients
Lidocaine hydrochloride .5 g/100g
Route TOPICAL
Dosage Form GEL
RxCUI drug identifier 1011849
Application Number part348
Labeler Name AO Biologix, LLC
Packages
Package NDC Code Description
82317-001-01 1 packet in 1 package (82317-001-01) / .5 g in 1 packet
82317-001-30 1 bottle in 1 carton (82317-001-30) / 30 g in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Lidocaine Hydrochloride 0.5%

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 Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily 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, Hydroxyethylcellulose, Disodium Phosphate, Sodium Phosphate, Methylparaben, Superoxide Dismutase, Propylparaben

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 For the temporary relief of pain

Purpose

Information about the drug product’s indications for use.
Purpose Lidocaine Hydrochloride 0.5%...............Topical Analgesic

Spl product data elements

Usually a list of ingredients in a drug product.
Serum X Lidocaine hydrochloride HYDROXYETHYL CELLULOSE, UNSPECIFIED SODIUM PHOSPHATE PROPYLPARABEN WATER LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS METHYLPARABEN SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE)

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.
AO Biologix Serum X Pain Relief Gel Fast Acting Lidocaine With Antioxidant Properties 30mL/1 Fl. oz. 1 2

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 in large quantities, particularly over raw surfaces or blistered areas

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 reacho f children. If swallowed, get medical help or contact a Poison Control Center right away.

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 855-910-1252 Monday-Friday; 9am-5pm MST. SerumX.com

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 doctor if condition worsens any allergic reaction occurs symptoms persist for more than 7 days or clear up and occur again within a few days

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 the eyes

Pregnancy or breast feeding

Pregnancy or Breast feeding
If pregnant or breastfeeding, ask a health professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store in a cool, dry place away from light this package is child-resistant

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 Do not use in large quantities, particularly over raw surfaces or blistered areas When using this product avoid contact with the eyes Stop use and ask doctor if condition worsens any allergic reaction occurs symptoms persist for more than 7 days or clear up and occur again within a few days If pregnant or breastfeeding, ask a health professional before use. Keep out of the reacho f children. If swallowed, get medical help or contact a Poison Control Center right away.

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