FDA.reportPublic FDA data

Topical Hemorrhoid Relief Gel

Manufacturer
Yantai Aien Biotechnology Co., Ltd.
Effective date
2026-03-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:50:56

Label at a glance#

ProductTopical Hemorrhoid Relief Gel
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Purpose
Menthol (0.1%).......Topical analgesic

OTC - PURPOSE SECTION

Uses
For the temporary relief of localdiscomfort, itching, and pain in theperianal area associated with
hemorrhoids and other anorectal
disorders

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenIf swallowed, get medical help orcontact a Poison Control Centerright away.

WARNINGS SECTION

Warnings
For external use only
Do not useI If you are allergic to menthol orany other ingredient in this product
When using this productAvoid contact with eyes. Ifcontact occurs, rinse thoroughly
with waterDo not put this product into therectum by using fingers or anymechanical device or applicator
Stop use and ask a doctor ifCondition worsens or does notimprove within 7 days
Bleeding occursRedness, irritation, swelling, pain,or other symptoms develop or
increaseAllergic reaction occurs

DOSAGE & ADMINISTRATION SECTION

Apply externally to the affectedarea up to 6 times daily

INDICATIONS & USAGE SECTION

DirectionsAdults: When practical, cleansethe affected area with mild soap
and warm water and rinsethoroughly. Gently dry by pattingor blotting with toilet tissue or asoft cloth before application of this
product.
Apply externally to the affectedarea up to 6 times daily
Children under 12 years of age:
consult a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients
Polihexanide, Riboflavin, Allantoin,
Sorbitol, Sodium Alginate,
Panthenol, Alkannin, Polyethylene
Glycol 200, Ferrous Sulfate,

87512-005-01 Topical Hemorrhoid Relief Gel 15g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

87512-005-0187512-005-01

87512-005-02 Topical Hemorrhoid Relief Gel 30g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

87512-005-0287512-005-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2739217menthol 0.1 % Rectal GelPSN1
2739217menthol 0.001 MG/MG Rectal GelSCD1
2739217menthol 0.1 % Rectal GelSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87512-005-01Topical Hemorrhoid Relief Gel15 g in 1 TUBEGEL151
87512-005-02Topical Hemorrhoid Relief Gel30 g in 1 TUBEGEL301

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87512-00587512-005-01, 87512-005-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
RIBOFLAVINTLM2976OFRIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
POLIHEXANIDE322U039GMFIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
WATER059QF0KO0RIACT
SODIUM ALGINATEC269C4G2ZQIACT
ALKANNIN075CRZ9995IACT
SORBITOL506T60A25RIACT
PANTHENOLWV9CM0O67ZIACT
FERROUS SULFATE39R4TAN1VTIACT
POLYETHYLENE GLYCOL 200R95B8J264JIACT
TROLAMINE9O3K93S3TKIACT

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
Topical Hemorrhoid Relief GelMENTHOL, UNSPECIFIED FORMYantai Aien Biotechnology Co., Ltd.4d6e6667-ab1c-de7c-e063-6294a90a0b9b2026-03-20WarningsExact identifier
ndc (package): 87512-005-01
ndc (package): 87512-005-02
ndc (product): 87512-005
ndc11 (package): 87512000502
ndc11 (package): 87512000501
spl id: 4d6e6667-ab1d-de7c-e063-6294a90a0b9b
spl set id: 4d6e6667-ab1c-de7c-e063-6294a90a0b9b

Reported adverse events (FAERS/openFDA)#

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