Hello Sugar Cream
FDA Label NDC 54723-031
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sambria Pharmaceuticals, Llc for the product Hello Sugar (NDC 54723-031). 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 drug facts, active ingredient, purpose, uses, warnings, 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
Active Ingredient
Lidocaine HCL 5.0% w/w
Purpose
Anorectal (Local Anesthetic)
Uses
For temporary relief of pain and discomfort
Warnings
For external use only.
Do not use on broken skin or if allergic to any ingredient.
When using this product use only as directed. Avoid contact with the eyes, rashes, or mucous membranes.
Stop use and ask doctor if condition worsens, or if symptoms persist for more than 7 days or return.
Keep out of reach of children and pets If swallowed get medical help or contact a Poison Control Center right away.
Directions
When Practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with tissue or a soft cloth before application.
Adults: Apply externally to the affected area.
Keep away from children under 12
Other Information
Protect this product from excessive heat and direct sun.
Inactive Ingredients
Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine
Product Label
Image Description (Image 31)
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