FDA Label for Curist 5% Lidocaine
View Indications, Usage & Precautions
Curist 5% Lidocaine Product Label
The following document was submitted to the FDA by the labeler of this product Little Pharma, 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.
Otc - Active Ingredient
Active ingredient
Lidocaine 5%
Phenylephrine HCL 0.25%
Otc - Purpose
Purpose
Anorectal (hemorrhoidal) spray
Indications & Usage
Uses
- temporarily shrinks hemorrhoidal tissue
■ temporarily reduces the swelling associated with irritation in
hemorrhoids and other anorectal disorders
■ for the temporary relief of pain
■ for the temporary relief of local itching and discomfort in the
perianal area
Warnings
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).
Otc - When Using
When using this product
- avoid contact with eyes
- do not exceed recommended dosage unless directed by a doctor
- do not put this product into the rectum by using fingers or any mechanical device or applicator
Otc - Stop Use
Stop use and ask a doctor if
- rectal bleeding occurs
- condition worsens or does not improve within 7 days
- allergic reaction occurs to ingredients in this product
- sumptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use
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:
• 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 Ingredient
Inactive ingredients Alcohol Denat., Aloe Barbadensis Leaf Extract, Benzophenone-4,
Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol, Polysorbate
20, Propylene Glycol, Sodium Citrate, Tocopheryl Acetate, Water
Otc - Questions
Questions Call 1-844-243-1241 or email [email protected]
Other
Distributed by:
Little Pharma, Inc. | New York, NY 10023
Made in USA With Globally Sourced Ingredients
Package Label.Principal Display Panel
curist
Lidocaine Spray
5% Spray
Anorectal (Hemorrhoidal) Spray
Temporary Relief of Pain, Itching, and Burning
Numbing Spray
Net Wt. 6 fl oz (177 ml)
* Please review the disclaimer below.
