Asutra WellHeal by BioLyte Laboratories, LLC

Asutra WellHeal by

Drug Labeling and Warnings

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

Drug Details [pdf]

ASUTRA WELLHEAL- salix alba bark, stellaria media, comfrey root, horse chestnut, daphne mezereum bark, equisetum arvense top, urtica urens, althaea officinalis root, hamamelis virginiana root bark/stem bark, calendula officinalis flowering top cream 
BioLyte Laboratories, LLC

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

----------

Active Ingredients

All active ingredients are HPUS* in equal proportions at 2X potency

Aesculus Hipp.,

Caledndula Off.,

Equisetum Arv.,

Symphytum Off.

Salix Alba,

Stellaria Med.

Althaea Off.,

Hamamelis Vir.

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

Active Ingredient Purpose

Aesculus Hipp.,

Caledndula Off.,

Equisetum Arv.,

Symphytum Off...................................... Promotes Wound Healing

Salix Alba,

Stellaria Med..........................................Topical Analgesic

Althaea Off.,

Hamamelis Vir........................................Anti-inflammatory

Uses

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

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 very large areas of the body
  • in the eyes

Stop use and ask doctor if:

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

Stop use and ask doctor if:

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

Keep out of reach of children.

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

Directions

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

Other Information

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

Inactive Ingredients:

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

Questions of Comments?

1-888-819-6472

Monday - Friday, 9am - 5pm CT

Report any serious side effects to number above.

Label Panel

Drug Panel ContentsAsutra WellHeal Vegan Panel 1

ASUTRA WELLHEAL 
salix alba bark, stellaria media, comfrey root, horse chestnut, daphne mezereum bark, equisetum arvense top, urtica urens, althaea officinalis root, hamamelis virginiana root bark/stem bark, calendula officinalis flowering top cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58368-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP2 [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 BARK2 [hp_X]  in 1 g
SALIX ALBA BARK (UNII: 205MXS71H7) (SALIX ALBA BARK - UNII:205MXS71H7) SALIX ALBA BARK2 [hp_X]  in 1 g
URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS2 [hp_X]  in 1 g
EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z) (EQUISETUM ARVENSE TOP - UNII:1DP6Y6B65Z) EQUISETUM ARVENSE TOP2 [hp_X]  in 1 g
DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK2 [hp_X]  in 1 g
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT2 [hp_X]  in 1 g
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT2 [hp_X]  in 1 g
STELLARIA MEDIA (UNII: 2H03479QVR) (STELLARIA MEDIA - UNII:2H03479QVR) STELLARIA MEDIA2 [hp_X]  in 1 g
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H) (ALTHAEA OFFICINALIS ROOT - UNII:TRW2FUF47H) ALTHAEA OFFICINALIS ROOT2 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
WATER (UNII: 059QF0KO0R)  
METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)  
CLOVE OIL (UNII: 578389D6D0)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYALURONIC ACID (UNII: S270N0TRQY)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILVER CITRATE (UNII: CKA421A1J7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58368-010-011 in 1 CARTON08/07/2020
128 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/07/202012/31/2023
Labeler - BioLyte Laboratories, LLC (015560564)
Establishment
NameAddressID/FEIBusiness Operations
BioLyte Laboratories, LLC015560564manufacture(58368-010)

Revised: 1/2024