Active Ingredient
Lidocaine Hydrochloride 0.5%
Serum X Gel
FDA Label NDC 82317-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ao Biologix, Llc for the product Serum X (NDC 82317-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Lidocaine Hydrochloride 0.5%...............Topical Analgesic
Uses
For the temporary relief of pain
Warnings
For external use only
Otc - Do Not Use
Do not use
- in large quantities, particularly over raw surfaces or blistered areas
Otc - When Using
When using this product
- avoid contact with the eyes
Otc - Stop Use
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of the reacho f children. If swallowed, get medical help or contact a Poison Control Center right away.
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
Other Information
- store in a cool, dry place away from light
- this package is child-resistant
Inactive Ingredients
Water, Hydroxyethylcellulose, Disodium Phosphate, Sodium Phosphate, Methylparaben, Superoxide Dismutase, Propylparaben
Questions Or Comments?
Call 855-910-1252 Monday-Friday; 9am-5pm MST.
SerumX.com
Package Label.Principal Display Panel
AO Biologix
Serum X
Pain Relief Gel
Fast Acting Lidocaine
With Antioxidant Properties
30mL/1 Fl. oz.
1 (Serum X Box Art Final Page 001)
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