CURIST HEMORRHOID FISSURE RELIEF- lidocaine cream

Curist Hemorrhoid Fissure Relief by

Drug Labeling and Warnings

Curist Hemorrhoid Fissure Relief 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 Ingredients

Glycerin 14.4%

Lidocaine 5%

Petrolatum 15%

Phenylephrine HCL 0.25%

Drug Facts

PURPOSE

Purpose

Hemorrhoidal Cream

WARNINGS

Warnings

For external use only

INDICATIONS & USAGE

Uses

• for the temporary reliedf of pain, soreness and burning
• helps relieve the local itching and discomfort associated with hemorrhoids
• temporarily shrinks hemorrhoidal tissue
• temporarily provides a coating for the relief of anorectal discomforts
• temporarily protects the inflamedm irritated abirectak syrface to help make bowel movements less painful

ASK DOCTOR

Ask a doctor before use if you have

• heart disease
• high blood pressure
• thyroid disease
• diabetes
• difficult in urination due to the enlargement of the prostate gland

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are presently taking a prescripton drug for high blood preassure or depression

WHEN USING

When using this product

• avoid contact with eyes
• do not exceed recommended dosage unless directed by a doctor
• do not put his product into rectum by using fingers or any mechanical device or applicator

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional before use.

STOP USE

Stop use and ask a doctor if

• rectal bleeding occurs
• condition worsens or does not imporve within seven (7) days
• allergic reaction occurs to ingredients in this product
• symptom being treated does not subside or if redness, irritation, swelling, pain or thor symptons develop or increase

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTHER SAFETY INFORMATION

If swallowed, get medical help or contact a Poison Control Center right sway (1-800-222-1222)

DOSAGE & ADMINISTRATION

Directions

• children under 12 years of age: consult a doctor
• adults: when practical, cleanse area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying
• apply externally to the affected area up to 4 times daily, especially at night, in the moring or after each bowel movement

STORAGE AND HANDLING

Other information

store at 15° - 30°C (59°-86°F)

INACTIVE INGREDIENT

Inactive Ingredients

aloe barbadensis leaf extract, BHA, cellulose gum, cetyl alcohol, citric acid, disodium EDTA, ethylhexylglycerin, glyceryl stearate, mineral oil, panthenol, phenoxyethanol, propyl gallate, propylene glycol, sorbitan olivate, steareth-21, stearyl alcohol, tocopherol, tocopheryl acetate, water, zanthan gum

QUESTIONS

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

SPL UNCLASSIFIED SECTION

Made in USA With Globally Sourced Ingedients

NDC: 72559-037-08

REV 037-08-01

Distributed by: Little Pharma, Inc.

New York, NY 10023

PRINCIPAL DISPLAY PANEL

curist

Hemorrhoid & Fissure Relief

Glycerin 14.%

Lidocaine 5%

Petrolatum 15%

Phenylephrine HCL 0.25%

Hemorrhoidal Cream

Provides a Soothing Protective Layer

Temporary Relief of Pain,

Itching, adn Burning

Reduces Swelling

Net Wt. 6 oz (170g)

INGREDIENTS AND APPEARANCE

CURIST HEMORRHOID FISSURE RELIEF 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72559-037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	15 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	14.4 g  in 100 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
MINERAL OIL (UNII: T5L8T28FGP)
BHA (UNII: REK4960K2U)
WATER (UNII: 059QF0KO0R)
CITRIC ACID (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CELLULOSE GUM (UNII: K679OBS311)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYL GALLATE (UNII: 8D4SNN7V92)
SORBITAN OLIVATE (UNII: MDL271E3GR)
STEARETH-21 (UNII: 53J3F32P58)
TOCOPHEROL (UNII: R0ZB2556P8)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
PANTHENOL (UNII: WV9CM0O67Z)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72559-037-08	170 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	05/01/2025

Labeler - Little Pharma, Inc (074328189)