Otc - Active Ingredient
Active ingredients: Purpose
Lidocaine HCl 4% .........................Topical Anesthetic
T-relief Lidocaine Hcl 4% Cream
FDA Label NDC 62795-6050
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medinatura New Mexico Inc. for the product T-relief Lidocaine Hcl 4% (NDC 62795-6050). 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 otc - active ingredient, otc - ask doctor, otc - do not use, otc - keep out of reach of children, otc - pregnancy or breast feeding, otc - purpose, otc - questions, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Ask Doctor
Stop use and ask a doctor:
If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.
Otc - Do Not Use
Do not use:
In large quantities, particularly over raw surfaces or blistered areas.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison
Control Center right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health
professional before use.
Otc - Purpose
Uses
For the temporary relief of pain. Also relieves itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor
skin irritations and rashes due to poison ivy.
Otc - Questions
Questions?
Call Weekdays 10am-6pm Eastern 1.844.MediNatura (1-844-633-4628) or email [email protected]
Otc - When Using
When using this product:
Use only as directed.
Avoid contact with eyes.
Warnings
For external use only
Dosage & Administration
Directions:
Twist off cap and remove foil seal.
Adults and children 4 years of age and
older: Apply to affected area not more than 3 to
4 times daily.
Children under 4 years of age: do not use,
consult a doctor.
Inactive Ingredient
Inactive ingredients
Organic Aloe vera oil (Organic Aloe vera powder,
Organic Soybean oil, Vitamin E), Arnica,
Calendula, Caprylic/Capric triglyceride, Carbopol
Ultrez 10, Carrageenan, Chamomille, Organic
Coconut oil, Echinacea, Hypericum, Millefolium,
Phenoxyethanol, Purified water, Organic Safflowe
oil, Organic Shea butter, Sodium hydroxide, Sodium
polyacrylate, Sunflower seed wax
Indications & Usage
- For the temporary relief of pain.
- Also relieves itching associated with minor burns, sunburn, minor cuts, scrapes, inspect bites, minor skin irritations and rashes due to poison ivy.
- For the temporary relief of pain.
- Also relieves itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations and rashes due to poison ivy.
* Please review the disclaimer below.
