WELLHEAL- aesculus hipp, calendula off, equisetum arv, symphytum off, salix alba, stellaria med, mezereum off, uritca urens, althaea off, hamamelis vir cream

WellHeal by

Drug Labeling and Warnings

WellHeal by is a Homeopathic medication manufactured, distributed, or labeled by Proximity Capital Partners LLC dba Asutra, BioLyte Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

All active ingredients are HPUS* in equal proportion at 3x potency

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

Salix Alba, Stellaria Med.

Mexereum Off., Urtica Urens

Althaea Off., Hamamelis Vir.

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

PURPOSE

All active ingredients are HPUS* in equal proportion at 3x potency

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

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

Mexereum 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

• 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

For external use only.

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

Stop use and ask doctor if:

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

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

DOSAGE & ADMINISTRATION

• 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

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

INACTIVE INGREDIENT

Aloe Vera Leaf Extract (BiAloe(R)), Carbomer, Caprylhydroxamic Acid, Citric Acid, Clove Oil, Silver Citrate, Emu Oil, Hyaluronic Acid, Methyl Glucose Dioleate, Potassium Sorbate, Purified Water, Sodium Hydroxide

QUESTIONS

1-888-819-6472

Monday - Friday, 9am - 5pm CT

Report any serious side effects to number above.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WELLHEAL 
aesculus hipp, calendula off, equisetum arv, symphytum off, salix alba, stellaria med, mezereum off, uritca urens, althaea off, hamamelis vir cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72683-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z) (EQUISETUM ARVENSE TOP - UNII:1DP6Y6B65Z)	EQUISETUM ARVENSE TOP	3 [hp_X]  in 1 g
SALIX ALBA BARK (UNII: 205MXS71H7) (SALIX ALBA BARK - UNII:205MXS71H7)	SALIX ALBA BARK	3 [hp_X]  in 1 g
STELLARIA MEDIA (UNII: 2H03479QVR) (STELLARIA MEDIA - UNII:2H03479QVR)	STELLARIA MEDIA	3 [hp_X]  in 1 g
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ)	HORSE CHESTNUT	3 [hp_X]  in 1 g
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	3 [hp_X]  in 1 g
DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV)	DAPHNE MEZEREUM BARK	3 [hp_X]  in 1 g
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9)	URTICA URENS	3 [hp_X]  in 1 g
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H) (ALTHAEA OFFICINALIS ROOT - UNII:TRW2FUF47H)	ALTHAEA OFFICINALIS ROOT	3 [hp_X]  in 1 g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	3 [hp_X]  in 1 g
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	3 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CLOVE OIL (UNII: 578389D6D0)
SILVER CITRATE (UNII: CKA421A1J7)
EMU OIL (UNII: 344821WD61)
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72683-001-01	1 in 1 CARTON	03/18/2019
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/18/2019

Labeler - Proximity Capital Partners LLC dba Asutra (081214985)

Establishment
Name	Address	ID/FEI	Business Operations
BioLyte Laboratories, LLC		015560564	manufacture(72683-001)