Label: ROSACEA SYMPTOM RELIEF- calendula officinalis, cardiospermum, chamomilla, hydrocotyle asiatica, rhus tox, thuja occidentalis cream
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-0919-3 - Packager: King Bio Inc.
- Category: HUMAN OTC DRUG LABEL
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 January 20, 2017
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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
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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)