87957-020Update

Manufacturer
Hubei Minxin Pharmaceutical Co., Ltd.
Effective date
2026-09-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-19 01:00:37

Label at a glance#

ProductRadthary BALANITIS RELIEF Cream
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP
Label structure13 sections

Dosage and administration

▪ cleanse the affected area with mild soap and water, pat dry ▪ dispense 2 pumps of cream onto clean fingers ▪ apply gently to the affected area 1 to 2 times daily ▪ massage until fully absorbed ▪ for first-time users, do a small patch test before full use

Storage and handling

▪ store at 59°F to 86°F (15°C to 30°C) ▪ claims based on homeopathic materia medica; not evaluated by the FDA for efficacy

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Calendula Officinalis 1X HPUS 4%
Homeopathic active ingredient

Purpose

OTC - PURPOSE SECTION

Soothes irritated skin

Use

INDICATIONS & USAGE SECTION

▪ temporarily helps relieve redness, itching and mild irritation of delicate male skin
▪ helps relieve chafed, chapped or cracked skin

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

▪ on children under 2 years of age unless directed by a doctor
▪ on deep or puncture wounds
▪ if you are allergic to any ingredient in this product

When Using

OTC - WHEN USING SECTION

▪ avoid contact with the eyes
▪ if contact occurs, rinse thoroughly with water

Stop Use

OTC - STOP USE SECTION

▪ symptoms persist for more than 7 days
▪ rash or irritation develops
▪ the condition worsens after initial improvement

Ask Doctor

OTC - ASK DOCTOR SECTION

▪ symptoms persist for more than 7 days
▪ rash or irritation develops
▪ the condition worsens after initial improvement

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.

Directions

DOSAGE & ADMINISTRATION SECTION

▪ cleanse the affected area with mild soap and water, pat dry
▪ dispense 2 pumps of cream onto clean fingers
▪ apply gently to the affected area 1 to 2 times daily
▪ massage until fully absorbed
▪ for first-time users, do a small patch test before full use

Other information

STORAGE AND HANDLING SECTION

▪ store at 59°F to 86°F (15°C to 30°C)
▪ claims based on homeopathic materia medica; not evaluated by the FDA for efficacy

Inactive ingredients

INACTIVE INGREDIENT SECTION

Bentonite, Caprylic/Capric Triglyceride,Cedarwood Oil, Cetyl Alcohol, Colloidal Oatmeal,Cottonseed Oil,Glycerin, Glyceryl Stearate SE,
Jojoba Oil, Lavender Oil

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

44

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-136980507550090GTIN-13: 6980507550090
EAN-13: 6980507550090
GTIN storage (14 digits): 06980507550090
46fea0563017a8c1d94e0963c4782671.jpg

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87957-02087957-020-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-09-14daily-update2026-09-16 01:00:43

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalendulaCALENDULA OFFICINALIS FLOWERING TOPLaboratoires Boiron2ed51803-5ec2-4163-ad12-2bf441551f072025-12-09WarningsName fallback
generic name: CALENDULA OFFICINALIS FLOWERING TOP
VagicalCALENDULA OFFICINALIS FLOWERING TOPFarmina sp. z o.o.0ab35c03-942e-4ba5-ba5a-65c5a99830d72025-01-30WarningsName fallback
generic name: CALENDULA OFFICINALIS FLOWERING TOP
CalendulaCALENDULA OFFICINALIS FLOWERING TOPLaboratoires Boironb775b879-6037-44a3-a5bd-045f2d923f3b2024-02-22WarningsName fallback
generic name: CALENDULA OFFICINALIS FLOWERING TOP
Calendula officinalisCALENDULA OFFICINALIS FLOWERING TOPBoiron8514140e-ec6a-24ee-e053-2a91aa0af06e2023-11-09Name fallback
generic name: CALENDULA OFFICINALIS FLOWERING TOP
Calendula officinalisCALENDULA OFFICINALIS FLOWERING TOPBoiron8514ae03-6c96-16cc-e053-2a91aa0a3cba2023-11-09Name fallback
generic name: CALENDULA OFFICINALIS FLOWERING TOP
Calendula officinalisCALENDULA OFFICINALIS FLOWERING TOPBoiron2818ca40-7c50-11e6-8378-424c583030312023-11-09Name fallback
generic name: CALENDULA OFFICINALIS FLOWERING TOP
Calendula officinalisCALENDULA OFFICINALIS FLOWERING TOPBoiron849d1bfd-62d8-3d47-e053-2991aa0aab832023-08-29Name fallback
generic name: CALENDULA OFFICINALIS FLOWERING TOP
Calendula officinalisCALENDULA OFFICINALIS FLOWERING TOPBoiron85148ed7-0554-e917-e053-2991aa0a32172023-06-05Name fallback
generic name: CALENDULA OFFICINALIS FLOWERING TOP
Calendula officinalisCALENDULA OFFICINALIS FLOWERING TOPBoiron849d3bcf-fc94-c605-e053-2991aa0afb2f2023-04-11Name fallback
generic name: CALENDULA OFFICINALIS FLOWERING TOP
Calendula officinalisCALENDULA OFFICINALIS FLOWERING TOPBoiron85146334-44fd-8dc5-e053-2a91aa0a03b52023-03-28Name fallback
generic name: CALENDULA OFFICINALIS FLOWERING TOP
CalendulaCALENDULA OFFICINALIS FLOWERING TOPLaboratoires Boiron25764f5a-378b-4103-81a1-2a6309e3e8e12023-03-16WarningsName fallback
generic name: CALENDULA OFFICINALIS FLOWERING TOP
Calendula officinalisCALENDULA OFFICINALIS FLOWERING TOPBoiron849d2a72-36cc-baca-e053-2a91aa0a1d142023-02-20Name fallback
generic name: CALENDULA OFFICINALIS FLOWERING TOP
CalendulaCALENDULA OFFICINALIS FLOWERING TOPLaboratoires Boiron7cd204b9-6716-40ca-96d4-40758fb1ce1f2023-02-06WarningsName fallback
generic name: CALENDULA OFFICINALIS FLOWERING TOP

Reported adverse events (FAERS/openFDA)#

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