Label: ECZEMA RESCUE- carbolicum acidum, fagopyrum esculentum, hydrastis canadensis, hydrocotyle asiatica, juglans regia, vinca minor lotion
- NDC Code(s): 43846-0008-1, 43846-0008-2
- Packager: Peaceful Mountain, Inc.
- 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 June 17, 2021
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS:
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INDICATIONS:
May temporarily relieve minor symptoms of eczema such as • Irritated • Red • Burning •Itching •Dry •Rough •Scaly •Chapped •Cracked skin •Rashes •Urticaria (hives) •Eruptions •Generally unhealthy skin.**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
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WARNINGS:
For external use only
When using this product • Do not get into eyes
Stop use and ask a doctor if • Condition worsens • Symptoms last more than 7 days
Allergy alert:Macadamia and Kukui Nut Oils • Soy
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
If pregnant or breast-feeding, ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
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INDICATIONS:
May temporarily relieve minor symptoms of eczema such as • Irritated • Red • Burning •Itching •Dry •Rough •Scaly •Chapped •Cracked skin •Rashes •Urticaria (hives) •Eruptions •Generally unhealthy skin.**
**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
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INACTIVE INGREDIENTS:
Purified Water, Poke (Berry) Phytolacca Americana, Olive Oil (Olea Europaea), Avocado Oil (Persea Americana), Macadamia Nut Oil (Macadamia Integrifolia), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10-30alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, PEG-33, PEG-8 Dimethicone, PEG-14, Kukui Nut Oil (Aleurites Moluccana, Polysorbate 20, Chaparral (Leaf) Larrea Tridentata, Poke (Root) Phytolacca Americana, Sodium Hydroxide (Solution), Arnica (Flower) Arnica Montana, St. John’s Wort (Aerial Parts) Hypericum Perforatum, White Willow (Bark) Salix Alba, Bloodroot (Root) Sanguinaria Canadensis, Comfrey (Leaf) Symphytum Officinale, Ascorbic Acid (Vitamin C Powder), Neem (Leaf) Azadirachta Indica, Calendula (Flower) Calendula Officinalis, Tocopherols (Vitamin E Oil) From Soy, Edetate Disodium (EDTA), Oregano, Potassium Sorbate, Sodium Benzoate, Ethanol, Citric Acid.
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
ECZEMA RESCUE
carbolicum acidum, fagopyrum esculentum, hydrastis canadensis, hydrocotyle asiatica, juglans regia, vinca minor lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43846-0008 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 1 g FAGOPYRUM ESCULENTUM (UNII: B10M69172N) (FAGOPYRUM ESCULENTUM - UNII:B10M69172N) FAGOPYRUM ESCULENTUM 30 [hp_X] in 1 g GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 30 [hp_X] in 1 g CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA 30 [hp_X] in 1 g JUGLANS REGIA LEAF (UNII: 85HKB87105) (JUGLANS REGIA LEAF - UNII:85HKB87105) JUGLANS REGIA LEAF 30 [hp_X] in 1 g JUGLANS REGIA FRUIT RIND, IMMATURE (UNII: ZPS7Q5U53K) (JUGLANS REGIA FRUIT RIND, IMMATURE - UNII:ZPS7Q5U53K) JUGLANS REGIA FRUIT RIND, IMMATURE 30 [hp_X] in 1 g VINCA MINOR (UNII: WGM46PQF02) (VINCA MINOR - UNII:WGM46PQF02) VINCA MINOR 30 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PHYTOLACCA AMERICANA FRUIT (UNII: WE63661499) OLIVE OIL (UNII: 6UYK2W1W1E) AVOCADO OIL (UNII: 6VNO72PFC1) MACADAMIA OIL (UNII: 515610SU8C) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBIC ACID (UNII: X045WJ989B) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ALOE VERA LEAF (UNII: ZY81Z83H0X) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) PEG-8 DIMETHICONE (UNII: GIA7T764OD) POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R) KUKUI NUT OIL (UNII: TP11QR7B8R) POLYSORBATE 20 (UNII: 7T1F30V5YH) LARREA TRIDENTATA LEAF (UNII: PK0TXD049P) PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) SODIUM HYDROXIDE (UNII: 55X04QC32I) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) SALIX ALBA BARK (UNII: 205MXS71H7) SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) COMFREY LEAF (UNII: DG4F8T839X) ASCORBIC ACID (UNII: PQ6CK8PD0R) AZADIRACHTA INDICA LEAF (UNII: HKY915780T) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) EDETATE DISODIUM (UNII: 7FLD91C86K) OREGANO (UNII: 0E5AT8T16U) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43846-0008-2 1 in 1 CARTON 08/11/2016 1 NDC:43846-0008-1 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 03/19/2013 Labeler - Peaceful Mountain, Inc. (078430707) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43846-0008) , api manufacture(43846-0008) , label(43846-0008) , pack(43846-0008)
