NDC | 57955-0921-3 |
Set ID | a4751819-d243-4c0d-b381-072070c141a5 |
Category | HUMAN OTC DRUG LABEL |
Packager | King Bio Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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ACTIVE INGREDIENT
Drug Facts__________________________________________________________________________________________________________
HPUS active ingredient Purpose†
Equal volumes of each active ingredient in 10X, 20X, and 30X potencies, unless otherwise noted.
Active ingredients 50% of total weight.
Cardiospermum* (2X, 10X, 20X, 30X), Hydrastis canadensis*, Hydrastis canadensis*, Lappa major*, Rhus tox*, Rumex crispus*, Ruta graveolens*, Sanguinaria canadensis*, Taraxacum officinale*.
*Certified organic Ingredient
**"HPUS"indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
- INDICATIONS & USAGE
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WARNINGS
Warnings
- For external use only. Avoid contact with eyes and broken skin.
- Stop use and ask a doctor if •increased skin irritation or other allergic reaction develops. •symptoms worsen or do not improve within 7 days.
- Nursing mothers should not apply to breast area.
- Keep out of reach of children.
- If swallowed, get medical help or contact a Poison Control Center immediately.
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredients: Aloe vera leaf juice powder*, avena sativa oat kernel flour*, carrageenan, chamomile recutita flower extract*, citrus extract*, glycerin, green tea extract*, honeysuckle extract*, lecithin*, licorice root extract*, neem seed oil*, oregon grape root extract*, organic alcohol*, oryza sativa race bran extract*, silicon dioxide, sucrose cocoate, sunflower oil*, water, xanthan gum.
*Certified organic Ingredient.
Certified organic by Oregon Tilth.
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PURPOSE
__________________________________________________________________________________________________________
HPUS active ingredient Purpose†
Equal volumes of each active ingredient in 10X, 20X, and 30X potencies, unless otherwise noted.
Active ingredients 50% of total weight.
Cardiospermum (2X, 10X, 20X, 30X)......................................................allergic skin eruption
Hydrastis canadensis..............................................................general unhealthy skin, eczema
Hydrocotyle asiatica.................................dry, eruptions, thickening of skin, exfoliation of scales
Lappa major...................................................................moist eruptions, greyish white crusts
Rhus tox........................................red, swollen, burning eczematous eruptions, scale formation
Rumex crispus.................................................................................intense itching, skin rash
Ruta graveolens......................................................................itching, inflamed, deep red skin
Sanguinaria canadensis...........................................................................redness and burning
Taraxacum officinale....................................................severe itching, skin rash, unhealthy skin
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ECZEMA SYMPTOM RELIEF
cardiospermum, hydrastis canadensis, hydrocotyle asiatica, lappa major, rhus tox, rumex crispus, ruta graveolens, sanguinaria canadensis, taraxacum officinale creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-0921 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR) (CARDIOSPERMUM HALICACABUM FLOWERING TOP - UNII:MZP2508BRR) CARDIOSPERMUM HALICACABUM FLOWERING TOP 2 [hp_X] in 85 g GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 10 [hp_X] in 85 g CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA 10 [hp_X] in 85 g ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT 10 [hp_X] in 85 g TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 10 [hp_X] in 85 g RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT 10 [hp_X] in 85 g RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP 10 [hp_X] in 85 g SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT 10 [hp_X] in 85 g TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE 10 [hp_X] in 85 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) OATMEAL (UNII: 8PI54V663Y) CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78) CHAMOMILE (UNII: FGL3685T2X) CITRUS BIOFLAVONOIDS (UNII: BD70459I50) GLYCERIN (UNII: PDC6A3C0OX) GREEN TEA LEAF (UNII: W2ZU1RY8B0) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) LICORICE (UNII: 61ZBX54883) AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T) MAHONIA AQUIFOLIUM ROOT (UNII: 746TB9VNDP) ALCOHOL (UNII: 3K9958V90M) RICE BRAN (UNII: R60QEP13IC) WATER (UNII: 059QF0KO0R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SUCROSE COCOATE (UNII: 3H18P0UK73) SUNFLOWER OIL (UNII: 3W1JG795YI) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-0921-3 1 in 1 CARTON 03/01/2017 1 85 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 03/01/2017 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(57955-0921)