NDC | 72683-001-01 |
Set ID | 8335e5ca-a2eb-d27a-e053-2a91aa0a7dc3 |
Category | HUMAN OTC DRUG LABEL |
Packager | Proximity Capital Partners LLC dba Asutra |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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ACTIVE INGREDIENT
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.
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PURPOSE
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
- WARNINGS
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WELLHEAL
aesculus hipp, calendula off, equisetum arv, symphytum off, salix alba, stellaria med, mezereum off, uritca urens, althaea off, hamamelis vir creamProduct 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 URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS 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 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) ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CLOVE OIL (UNII: 578389D6D0) SILVER CITRATE (UNII: CKA421A1J7) 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)