FDA.reportPublic FDA data

WellHeal

Manufacturer
Proximity Capital Partners LLC dba Asutra | BioLyte Laboratories, LLC
Effective date
2020-12-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:57

Label at a glance#

ProductWellHeal
Active ingredientEQUISETUM ARVENSE TOP, SALIX ALBA BARK, STELLARIA MEDIA, URTICA URENS, HORSE CHESTNUT, COMFREY ROOT, DAPHNE MEZEREUM BARK, ALTHAEA OFFICINALIS ROOT, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, CALENDULA OFFICINALIS FLOWERING TOP
Label structure9 sections

Storage and handling

Store in a cool, dry place Avoid direct sunlight Tamper-evident for your protection. Use only if safety seal is intact.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

All active ingredients are HPUS* in equal proportion at 2x potency

Aesculus Hipp., Calendula Off., Equisetum Arv., Symphytum Off.

Salix Alba, Stellaria Med.

Mezereum Off., Urtica Urens

Althaea Off., Hamamelis Vir.

*HPUS indicates active ingredients are in the official Homeopathic Pharmacopeia of the United States.

OTC - PURPOSE SECTION

All active ingredients are HPUS* in equal proportion at 2x potency

Aesculus Hipp., Calendula Off., Equisetum Arv., Symphytum Off. ................................Promotes Wound Healing

Salix Alba, Stellaria Med. ......................................Topical Analgesic

Mezereum Off., Urtica Urens ................................ Reduces Itching

Althaea Off., Hamamelis Vir. .................................Anti-inflammatory

*HPUS indicates active ingredients are in the official Homeopathic Pharmacopeia of the United States.

INDICATIONS & USAGE SECTION

  • Helps reduce potential infection in minor cuts, scrapes, and abrasions.
  • For temporary relief of itchiness and soreness.
  • Promotes wound healing.

Indications are based on Materia Medica, not clinical tests.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use if you have:

  • deep or puncture wounds
  • animal bites
  • serious burns
  • rash develops

-----

Do not use:

  • over large areas of the body
  • in eyes

OTC - STOP USE SECTION

Stop use and ask doctor if:

  • condition worsens or lasts more than 1 week
  • symptoms clear up and reoccur within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
  • apply a small amount of this product on the area 2 to 3 times daily
  • may be covered with a steril bandage

STORAGE AND HANDLING SECTION

  • Store in a cool, dry place
  • Avoid direct sunlight
  • Tamper-evident for your protection. Use only if safety seal is intact.

INACTIVE INGREDIENT SECTION

Colloidal Silver Citrate, Purified Water, Caprylyl Glycol, Aloe Vera Barbadensis (BiAloe), Methyl Glucose Dioleate, Carbomer, Sodium Hydroxide, Baobab Oil, Clove Oil, Potassium Sorbate, Citric Acid, Hyaluronic Acid

OTC - QUESTIONS SECTION

1-888-819-6472

Monday - Friday, 9am - 5pm CT

Report any serious side effects to number above.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

001001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72683-001-01WellHeal1 in 1 CARTONCREAM12
72683-001-01WellHeal28 g in 1 TUBECREAM282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72683-001WELLHEAL (AESCULUS HIPP, CALENDULA OFF, EQUISETUM ARV, SYMPHYTUM OFF, SALIX ALBA, STELLARIA MED, MEZEREUM OFF, URITCA URENS, ALTHAEA OFF, HAMAMELIS VIR) CREAM [PROXIMITY CAPITAL PARTNERS LLC DBA ASUTRA]2Current NDC, Legacy NDC, 2 package rows20201209_8335e5ca-a2eb-d27a-e053-2a91aa0a7dc3.zip

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
72683-00172683-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
EQUISETUM ARVENSE TOP1DP6Y6B65ZACTIB
SALIX ALBA BARK205MXS71H7ACTIB
STELLARIA MEDIA2H03479QVRACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ADANSONIA DIGITATA SEED OIL77MKL7AR5IIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYL GLUCOSE DIOLEATEFA9KFJ4Z6PIACT
URTICA URENSIHN2NQ5OF9ACTIB
HORSE CHESTNUT3C18L6RJAZACTIB
COMFREY ROOTM9VVZ08EKQACTIB
DAPHNE MEZEREUM BARKX2N6E405GVACTIB
ALTHAEA OFFICINALIS ROOTTRW2FUF47HACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
CLOVE OIL578389D6D0IACT
SILVER CITRATECKA421A1J7IACT
HYALURONIC ACIDS270N0TRQYIACT

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
WellHealAESCULUS HIPP, CALENDULA OFF, EQUISETUM ARV, SYMPHYTUM OFF, SALIX ALBA, STELLARIA MED, MEZEREUM OFF, URITCA URENS, ALTHAEA OFF, HAMAMELIS VIRProximity Capital Partners LLC dba Asutra8335e5ca-a2eb-d27a-e053-2a91aa0a7dc32020-12-07WarningsExact identifier
ndc (package): 72683-001-01
ndc (product): 72683-001
ndc11 (package): 72683000101
spl id: b5eace4d-3cf8-0b66-e053-2995a90a20ba
spl set id: 8335e5ca-a2eb-d27a-e053-2a91aa0a7dc3

Reported adverse events (FAERS/openFDA)#

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