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

Rosacea Symptom Relief by

Drug Labeling and Warnings

Rosacea Symptom Relief by is a Homeopathic medication manufactured, distributed, or labeled by King Bio Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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.

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

• Keep out of reach of children.

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information:

• To open: unscrew cap, remove tube seal, replace cap.
• Safety sealed for your protection.
• Do not use if tube seal is missing.
• Store at 68-77° (20-25°C).
• Certified organic topical lotion.

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.

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

INGREDIENTS AND APPEARANCE

ROSACEA SYMPTOM RELIEF 
calendula officinalis, cardiospermum, chamomilla, hydrocotyle asiatica, rhus tox, thuja occidentalis cream

Product 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)