Label: ECZEMA REMEDY- carbolicum acidum, fagopyrum esculentum, hydrastis canadensis, hydrocotyle asiatica, juglans regia, vinca minor lotion
- NDC Code(s): 68703-214-04
- Packager: Silver Star Brands
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated March 4, 2023
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- HPUS Active Ingredients
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Uses*
Indications*: May temporarily relieve signs and symptoms associated with eczema such as rashes, hives, eruptions, and skin inflammation as well as temporarily soothe skin that is red, burning, itchy, dry, scaly, chapped or cracked.
*As per various homeopathic materia medicas. These indications have not been evaluated by the FDA, and product has not been clinically tested.
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Warnings
Warnings: If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. For external use only. Avoid using near eyes or mouth. If swallowed, get medical help or contact a Poison Control Center immediately. Some individuals may be sensitive to ingredients, if irritiation or reaction occurs, discontinue use. Intended to complement, not replace, standard medical care.
- Directions
- OTHER SAFETY INFORMATION
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Inactive Ingredients
Purified Water, Phytolacca Americana (Poke) Berry Extract, Olea Europaea (Olive) Oil, Persea Gratissima (Avocado) Oil, Macadamia Integrifolia Seed Oil, Phenoxyethanol & Caprylyl Glycol & Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, PEG-33 & PEG-8 Dimethicone & PEG-14, Aleurites Moluccana (Kukui) Seed Oil, Polysorbate 20, Larrea Tridentata (Chaparral) Leaf Extract, Phytolacca Americana (Poke) Root Extract, Sodium Hydroxide, Arnica Montana (Arnica) Flower Extract, Hypericum Perforatum (St. John's Wort) Aerial Parts Extract, Salix Alba (White Willow) Bark Extract, Ascorbic Acid, Azadirachta Indica (Neem) Leaf Extract, Calendula Officinalis (Calendula) Flower Extract, Tocopherols (soy), Edetate Disodium, Natural Plant Extract and Potassium Sorbate. Allergy alert: Macadamia and Kukui Nut Oils and Soy.
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ECZEMA REMEDY
carbolicum acidum, fagopyrum esculentum, hydrastis canadensis, hydrocotyle asiatica, juglans regia, vinca minor lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68703-214 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL 30 [hp_X] in 113 g CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA 30 [hp_X] in 113 g FAGOPYRUM ESCULENTUM (UNII: B10M69172N) (FAGOPYRUM ESCULENTUM - UNII:B10M69172N) FAGOPYRUM ESCULENTUM 30 [hp_X] in 113 g JUGLANS REGIA LEAF (UNII: 85HKB87105) (JUGLANS REGIA LEAF - UNII:85HKB87105) JUGLANS REGIA LEAF 30 [hp_X] in 113 g VINCA MINOR (UNII: WGM46PQF02) (VINCA MINOR - UNII:WGM46PQF02) VINCA MINOR 30 [hp_X] in 113 g HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T) (HYDRASTIS CANADENSIS WHOLE - UNII:R763EBH88T) HYDRASTIS CANADENSIS WHOLE 30 [hp_X] in 113 g Inactive Ingredients Ingredient Name Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) AZADIRACHTA INDICA LEAF (UNII: HKY915780T) SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBIC ACID (UNII: X045WJ989B) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) MACADAMIA ACID (UNII: 7N137Q0QYJ) ALOE VERA LEAF (UNII: ZY81Z83H0X) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) KUKUI NUT OIL (UNII: TP11QR7B8R) LARREA TRIDENTATA LEAF (UNII: PK0TXD049P) HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) POLYSORBATE 20 (UNII: 7T1F30V5YH) PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) SALIX ALBA BARK (UNII: 205MXS71H7) PEG-8 DIMETHICONE (UNII: GIA7T764OD) POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R) SODIUM HYDROXIDE (UNII: 55X04QC32I) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) EDETATE DISODIUM (UNII: 7FLD91C86K) COMFREY LEAF (UNII: DG4F8T839X) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) TOCOPHEROL (UNII: R0ZB2556P8) AVOCADO OIL (UNII: 6VNO72PFC1) WATER (UNII: 059QF0KO0R) PHYTOLACCA AMERICANA FRUIT (UNII: WE63661499) BLACK OLIVE (UNII: 2M6QWV94OC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68703-214-04 113 g in 1 JAR; Type 0: Not a Combination Product 12/11/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/11/2017 Labeler - Silver Star Brands (006070379) Registrant - Silver Star Brands (006070379) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(68703-214)
