Statement Of Identity
Restoriden Nutrition LIDOCAINE PAIN RELIEF CREAM
Restoriden Lidocaine Cream
FDA Label NDC 76348-583
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Renu Laboratories, Inc. for the product Restoriden Lidocaine Cream (NDC 76348-583). 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 statement of identity, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Lidocaine HCl 4%
Otc - Purpose
Purpose
Topical anesthetic
Indications & Usage
Uses: to reduce pain or discomfort caused by skin irritations such as sunburn, insect bites, poison ivy, poison oak, poison sumac, and minor cuts, scratches or burns.
Warnings
For External Use only
Otc - When Using
When using this product, do not use in or near the eyes
- do not use in large quantities, particularly over raw surfaces or blistered areas.
Otc - Stop Use
Stop Use and ask a doctor if:
- allergic reaction occurs
- condition worsens or does not improve within 7 days
- symptoms clear up and return within a few days
- redness, irritation, swelling, pain or other symptoms begin.
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.
Dosage & Administration
Directions: adults and children 2 years and older apply externally to the affected area up to 3 to 4 times a day
Children under 2 years, ask a doctor
Other Safety Information
May be applied under occlusive dressing
Store at 20 - 25° C
Otc - Questions
Inactive Ingredient
Arnica Montana Extract, Capryl Glycol, Caprylic/Capric Triglycerides, Cetearyl Alcohol, Deionized Water, Emulsifying Wax NF, Ethylhexylglycerin, Glycerin,Hexylene Glycol, Hippophae Rhamnoides Fruit and Seed Oils, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Stearic Acid, Tetrasodium EDTA, Tocopherol
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PRODUCT LABEL
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