CURIST 5% LIDOCAINE- lidocaine 5% spray

Curist 5% Lidocaine by

Drug Labeling and Warnings

Curist 5% Lidocaine by is a Otc medication manufactured, distributed, or labeled by Little Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Lidocaine 5%

Phenylephrine HCL 0.25%

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).

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

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

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

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

QUESTIONS

Questions Call 1-844-243-1241 or email hi@curistrelief.com

SPL UNCLASSIFIED SECTION

Distributed by:

Little Pharma, Inc. | New York, NY 10023

Made in USA With Globally Sourced Ingredients

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)

INGREDIENTS AND APPEARANCE

CURIST 5% LIDOCAINE 
lidocaine 5% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72559-034
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	500 g  in 100 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
DEHYDRATED ALCOHOL (UNII: 3K9958V90M)
BENZOPHENONE-4 (UNII: 1W6L629B4K)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE BARBADENSIS LEAF JUICE POWDER (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72559-034-57	177 mL in 1 CAN; Type 0: Not a Combination Product	12/26/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	12/27/2023

Labeler - Little Pharma, Inc. (074328189)