Curist Lidocaine 5% Spray

Curist Lidocaine 5% Spray
SPL v3
SPL
SPL Set ID f20241a2-c5b1-f124-e053-2995a90a891b
Route
TOPICAL
Published
Effective Date 2024-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (500 g)
Inactive Ingredients
Water Sodium Citrate Dehydrated Alcohol Benzophenone-4 Edetate Disodium Ethylhexylglycerin Polysorbate 20 .alpha.-tocopherol Acetate Aloe Vera Leaf Phenoxyethanol Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-27

Description

Active ingredient Lidocaine 5% Phenylephrine HCL 0.25%


Medication Information

Warnings and Precautions

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).






Indications and 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
Dosage and 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.

Description

Active ingredient Lidocaine 5% Phenylephrine HCL 0.25%

Section 42229-5

Distributed by:

Little Pharma, Inc. | New York, NY 10023

Made in USA With Globally Sourced Ingredients

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9

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
Section 50567-7

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
Section 51727-6

Inactive ingredients Alcohol Denat., Aloe Barbadensis Leaf Extract, Benzophenone-4,

Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol, Polysorbate

20, Propylene Glycol, Sodium Citrate, Tocopheryl Acetate, Water

Section 51945-4

curist

Lidocaine Spray

5% Spray

Anorectal (Hemorrhoidal) Spray

Temporary Relief of Pain, Itching, and Burning

Numbing Spray

Net Wt. 6 fl oz (177 ml)

Section 53413-1

Questions Call 1-844-243-1241or email [email protected]

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use

Section 55105-1

Purpose

Anorectal (hemorrhoidal) spray

Section 55106-9

Active ingredient

Lidocaine 5%

Phenylephrine HCL 0.25%


Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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).






Section 42229-5 (42229-5)

Distributed by:

Little Pharma, Inc. | New York, NY 10023

Made in USA With Globally Sourced Ingredients

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

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
Section 51727-6 (51727-6)

Inactive ingredients Alcohol Denat., Aloe Barbadensis Leaf Extract, Benzophenone-4,

Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol, Polysorbate

20, Propylene Glycol, Sodium Citrate, Tocopheryl Acetate, Water

Section 51945-4 (51945-4)

curist

Lidocaine Spray

5% Spray

Anorectal (Hemorrhoidal) Spray

Temporary Relief of Pain, Itching, and Burning

Numbing Spray

Net Wt. 6 fl oz (177 ml)

Section 53413-1 (53413-1)

Questions Call 1-844-243-1241or email [email protected]

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use

Section 55105-1 (55105-1)

Purpose

Anorectal (hemorrhoidal) spray

Section 55106-9 (55106-9)

Active ingredient

Lidocaine 5%

Phenylephrine HCL 0.25%


Advanced Ingredient Data


Raw Label Data

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