NDC | 57955-0919-3 |
Set ID | a6569a43-a207-4a5f-b059-8964f5732ae1 |
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.
Calendula officinalis, Cardiospermum (2X, 10X, 20X, 30X), Chamomilla, Hydrocotyle asiatica, Rhus tox, Thuja occidentalis (3X, 10X, 20X, 30X).
*"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
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INDICATIONS & USAGE
Uses for temporary relief of multiple symptoms of rosacea: •facial redness •burning •stinging •allergic skin eruptions •itching •dermatitis •pimples •swelling •thickening of skin.
† as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.
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WARNINGS
Warnings
- For external use only. Avoid contact with eyes.
- Stop use and ask a doctor if •increased skin irritation, pimples, redness 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.
Calendula officinalis........................................................................burning, stinging, puffy face
Cardiospermum (2X, 10X, 20X, 30X)......................................flush of heat, allergic skin eruptions
Chamomilla....................................................................................................red and hot skin
Hydrocotyle asiatica.....................................................rosacea, skin disorders, thickening of skin
Rhus tox...................................................swelling, redness, pimples, itching, dermatitis, rosacea
Thuja occidentalis (3X, 10X, 20X, 30X).............long-term skin troubles, sensitive skin, burning heat
and facial redness
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROSACEA SYMPTOM RELIEF
calendula officinalis, cardiospermum, chamomilla, hydrocotyle asiatica, rhus tox, thuja occidentalis creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-0919 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 10 [hp_X] in 83 g CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR) (CARDIOSPERMUM HALICACABUM FLOWERING TOP - UNII:MZP2508BRR) CARDIOSPERMUM HALICACABUM FLOWERING TOP 2 [hp_X] in 83 g MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 10 [hp_X] in 83 g CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA 10 [hp_X] in 83 g TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 10 [hp_X] in 83 g THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 3 [hp_X] in 83 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) OATMEAL (UNII: 8PI54V663Y) CARRAGEENAN (UNII: 5C69YCD2YJ) 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:57955-0919-3 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(57955-0919)