FDA Label for Restoriden Lidocaine Cream
View Indications, Usage & Precautions
Restoriden Lidocaine Cream Product Label
The following document was submitted to the FDA by the labeler of this product Renu Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Statement Of Identity
Restoriden Nutrition LIDOCAINE PAIN RELIEF CREAM
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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