Otc - Active Ingredient
Active ingredient
Lidocaine 5%
Phenylephrine HCL 0.25%
The following Structured Product Label (SPL) was submitted to the FDA by Little Pharma, Inc. for the product Curist 5% Lidocaine (NDC 72559-034). 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 - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient
Lidocaine 5%
Phenylephrine HCL 0.25%
Purpose
Anorectal (hemorrhoidal) spray
Uses
Warnings
For external use only
Flamable, Do not use while smoking or near heat ot flame
When using this product
■ avoid spraying in eyes
■ do not puncture or incinerate
■ do not store at temperature above 86 F
■ do not exceed recommended daily dosage unless directed
by doctor
■ do not put this product into rectum by using fingers or any
mechanical device or applicator
Ask a doctor before use if you have
■ heart disease
■ high blood pressure
■ thyroid disease
■ diabetes
■ difficulty in urination due to enlargement of prostate gland
Ask a doctor or pharmacist before use if you are
■ presently taking a prescription drug for high blood pressure
or depression
Stop use and ask doctor if
■ condition worsens or does not improve within 7 days
■ bleeding occurs
■ the symptom being treated does not subside or if redness,
irritation, swelling, pain, or other symptoms develop or increase.
Certain persons can develop allergic reactions to ingredients in
this product.
If pregnant or breastfeeding, ask a healthcare professional
before use.
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center immediately (1-800-222-1222).
When using this product
Stop use and ask a doctor if
If pregnant or breastfeeding, ask a health professional before use
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Directions
Adults:
• When practical, cleanse the affected area with mild soap and
warm water and rinse thoroughly. Gently dry by patting or
blotting with toilet tissue or a soft cloth before application of
this product.
• Apply externally to the affected area up to 4 times daily.
■ Children under 12 years of age: consult a doctor.
Inactive ingredients Alcohol Denat., Aloe Barbadensis Leaf Extract, Benzophenone-4,
Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol, Polysorbate
20, Propylene Glycol, Sodium Citrate, Tocopheryl Acetate, Water
Questions Call 1-844-243-1241 or email [email protected]
Distributed by:
Little Pharma, Inc. | New York, NY 10023
Made in USA With Globally Sourced Ingredients
curist
Lidocaine Spray
5% Spray
Anorectal (Hemorrhoidal) Spray
Temporary Relief of Pain, Itching, and Burning
Numbing Spray
Net Wt. 6 fl oz (177 ml)
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