FDA.reportPublic FDA data

Flarestop Hemorrhoid Cream Lidocaine 5%

Manufacturer
Chelsea Pharmacceuticals LLC | Pure Source, LLC
Effective date
2026-09-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-12 01:01:20

Label at a glance#

ProductFlarestop Hemorrhoid Lidocaine
Active ingredientLIDOCAINE
Label structure7 sections

Indications and uses

Helps relieve the local itching and discomfort in the perianal area. For the temporary relief of pain, irritation or burning.

Dosage and administration

Adults: When practical, cleanse the affected area with mild soap and warm water and rinse by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Children under 12 years of age: consult a doctor. Apply externally to the affected area up to 6 times daily.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5.00 %

Purpose

OTC - PURPOSE SECTION

Local Anesthetic (anorectal)

Uses

INDICATIONS & USAGE SECTION

  • Helps relieve the local itching and discomfort in the perianal area.
  • For the temporary relief of pain, irritation or burning.

Warnings

WARNINGS SECTION

For external use only

Do Not

OTC - DO NOT USE SECTION

  • Exceed the recommended daily dosage unless directed by a doctor.
  • put this product into the rectum by using your fingers or any mechanical device or applicator.

When using this product

OTC - WHEN USING SECTION

  • If the condition worsens or does not improve within 7 days, consult a doctor.
  • In case of bleeding, consult a doctor promptly.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • If the symptoms being treated do not subside or if redness,
  • irritation, swelling, pain, or other symptoms develop or increase.

Allergy alert

  • Certain persons can develop allergic reactions to ingredients in this product.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults:

  • When practical, cleanse the affected area with mild soap and warm water and rinse by patting or blotting with an appropriate cleansing pad.
  • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • Children under 12 years of age: consult a doctor.
  • Apply externally to the affected area up to 6 times daily.

Other information

SPL UNCLASSIFIED SECTION

  • Protect from excessive heat and direct sun. Store at 20-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf Juice, Bisabolol, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetearyl Alcohol, Citric Acid, Dimethicone, Ethoxydiglycol, Glycerin, Glyceryl Stearate Citrate, Glycyrrhiza Glabra (Licorice) Root Extract, 1,2-Hexanediol, Isopropyl Myristate, Panthenol, Pentylene Glycol, Polyacrylate Crosspolymer-6, Sodium Hyaluronate, Sodium Phytate, Tocopheryl Acetate, Water (Aqua).

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130884400715227GTIN-13: 0884400715227
EAN-13: 0884400715227
GTIN-12: 884400715227
UPC-A: 884400715227
GTIN storage (14 digits): 00884400715227		Outer Package.jpg

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87989-01387989-013-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAF JUICERUE8E6T4NBIACT
BISABOLOL24WE03BX2TIACT
SHEA BUTTERK49155WL9YIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIMETHICONE92RU3N3Y1OIACT
ETHOXYDIGLYCOLA1A1I8X02BIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
GLYCYRRHIZA GLABRA (LICORICE) ROOT POWDER2788Z9758HIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
PANTHENOLWV9CM0O67ZIACT
PENTYLENE GLYCOL50C1307PZGIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
SODIUM HYALURONATEYSE9PPT4THIACT
PHYTATE SODIUM88496G1ERLIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flarestop Hemorrhoid LidocaineLIDOCAINEChelsea Pharmacceuticals LLCb8a589f7-7131-4807-9bcb-84af3078e2582026-09-10WarningsExact identifier
ndc (package): 87989-013-00
ndc (product): 87989-013
ndc11 (package): 87989001300
spl id: 5b08135d-6813-2a1e-e063-6394a90abc28
spl set id: b8a589f7-7131-4807-9bcb-84af3078e258

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.