Active Ingredient(S)
Lidocaine HCI 3.5%
Sunset Novelties Herquake Liquid
FDA Label NDC 85243-111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sunset Intimates Group Inc for the product Sunset Novelties Herquake (NDC 85243-111). 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(s), purpose, use, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External Analgesic
Use
For temporary relief of pain, soreness or burning in the perianal area.
Warnings
For external use only. Do not use this product with a mechanical device.
Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.
Do not exceed the daily recommended dosage.
In case of any bleeding, discontinue use and consult a doctor.
Keep this and all drugs out of reach of children. In case of accidential overdose, seek medical help or call a Poison Control Center right away.
As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.
Otc - Keep Out Of Reach Of Children
Keep out of reach of childeren.
Directions
Apply to any area of the body where you desire extra moisture. Secure cap.
Apply externally to the affected area up to 6 times
Other Information
Store at 20-25°C (68-77°F)
Inactive Ingredients
Purified Water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, Sodium Benzoate, Potassium Sorbate, Citric Acid
Package Label - Principal Display Panel
118 mL NDC: 85243-111-11
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