ROSACEA SYMPTOM RELIEF- calendula officinalis, cardiospermum, chamomilla, hydrocotyle asiatica, rhus tox, thuja occidentalis cream 
King Bio Inc.

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.

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Rosacea Symptom Relief

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.

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.

Warnings

Directions

•Shake before using. •Adults & children 2 years of age and older: apply to affected area up to 4 times daily. Rub in gently. •Children under 2 years of age: consult a doctor. •Patch test recommended on sensitive skin.

Other information:

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.

__________________________________________________________________________________________________________

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

image description

ROSACEA SYMPTOM RELIEF 
calendula officinalis, cardiospermum, chamomilla, hydrocotyle asiatica, rhus tox, thuja occidentalis cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0919
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP10 [hp_X]  in 83 g
CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR) (CARDIOSPERMUM HALICACABUM FLOWERING TOP - UNII:MZP2508BRR) CARDIOSPERMUM HALICACABUM FLOWERING TOP2 [hp_X]  in 83 g
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA10 [hp_X]  in 83 g
CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA10 [hp_X]  in 83 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF10 [hp_X]  in 83 g
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG3 [hp_X]  in 83 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57955-0919-31 in 1 CARTON03/01/2017
185 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/01/2017
Labeler - King Bio Inc. (617901350)
Registrant - King Bio Inc. (617901350)
Establishment
NameAddressID/FEIBusiness Operations
King Bio Inc.617901350manufacture(57955-0919)

Revised: 1/2017
Document Id: f566190d-1c29-406e-8c3e-9a3d6cb632e8
Set id: a6569a43-a207-4a5f-b059-8964f5732ae1
Version: 3
Effective Time: 20170120
 
King Bio Inc.