ECZEMA REMEDY- carbolicum acidum, fagopyrum esculentum, hydrastis canadensis, hydrocotyle asiatica, juglans regia, vinca minor lotion

Eczema Remedy by

Drug Labeling and Warnings

Eczema Remedy by is a Homeopathic medication manufactured, distributed, or labeled by Silver Star Brands, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HPUS Active Ingredients

HPUS** Active Ingredients: Carbolicum acidum 30X, Fagopyrum esculentum 30X, Hydrastis canadensis 30X, Hydrocotyle asiatica 30X, Juglans regia 30X, Vinca minor 30X.

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

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.

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

Apply to affected areas at least 3 times per day. Children under 12 years of age: consult a doctor before use.

OTHER SAFETY INFORMATION

Paraben free. No petroleum. No animal testing. No artificial colors or fragrances.

Tamper resistant for your protection. Use only if safety seal is intact.

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

Keep out of reach of children.

PREGNANCY OR BREAST FEEDING

If pregnant or breastfeeding, ask a health professional before use.

PURPOSE

Homeopathic Lotion

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ECZEMA REMEDY 
carbolicum acidum, fagopyrum esculentum, hydrastis canadensis, hydrocotyle asiatica, juglans regia, vinca minor lotion

Product 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
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
CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U)	CENTELLA ASIATICA	30 [hp_X]  in 113 g
PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV)	PHENOL	30 [hp_X]  in 113 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHYTOLACCA AMERICANA FRUIT (UNII: WE63661499)
BLACK OLIVE (UNII: 2M6QWV94OC)
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)
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)
AVOCADO OIL (UNII: 6VNO72PFC1)
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)

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)