H-ROSACEA FORMULA- belladonna, nux vomica oil

H-Rosacea Formula by

Drug Labeling and Warnings

H-Rosacea Formula by is a Homeopathic medication manufactured, distributed, or labeled by Healing Natural Oils LLC, King Bio Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Belladonna - 6C HPUS
Nux vomica -12C HPUS  

Purpose

Belladonna - 6C HPUS (rosacea, acne)
Nux vomica -12C HPUS (skin red and blotchy)

The letters ‘HPUS’ indicate that the components in this product are officially
monographed in the Homoeopathic Pharmacopoeia of the United States

Inactive Ingredients:

Corylus avellana nut oil, Essential Oil Blend (Cupressus   
sempervirens leaves and twigs, Daucus carota seed, Helichrysum italicum flower,   
Lavandula officinalis flower bud, Matricaria recutita flower, Melaleuca alternifolia   
leaf-branch, Pelargonium graveolens whole plant).

Indications:

For the temporary relief of rosacea symptoms such as redness and irritation

Directions:

Adults and Children 4 yrs and over: Wash hands before and after use.
Shake well and apply 1 or 2 drops to a cotton swab or your fingers and apply directly to the affected area 3x per day.
Do not oversaturate or exceed dosage.

Warnings:

For external use only.

Perform skin test prior to initial use.

Do not use if pregnant or breastfeeding.

Keep out of reach of children.

Keep away from eyes and mucous membranes. If swallowed get medical help
or contact a Poison Control Center right away.

Discontinue use if irritation occurs.

Consult a doctor if symptoms worsen after 7 days.

DESCRIPTION

Dist. by Healing Natural Oils 3830 Valley Ctr Dr, #705-526, San Diego, CA 92130, USA

PRINCIPAL DISPLAY PANEL

Healing Natural Oils

H-Rosacea
Formula

Homeopathic

For External Use Only

121

11ml (0.37 fl. oz)
amoils.com

INGREDIENTS AND APPEARANCE

H-ROSACEA FORMULA  
belladonna, nux vomica oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61077-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	6 [hp_C]  in 11 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	12 [hp_C]  in 11 mL

Inactive Ingredients
Ingredient Name	Strength
EUROPEAN HAZELNUT OIL (UNII: 8RQ2839AVG)
CUPRESSUS SEMPERVIRENS LEAFY TWIG (UNII: 7HB6L93P3U)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
CARROT SEED OIL (UNII: 595AO13F11)
HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)
CHAMOMILE (UNII: FGL3685T2X)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
PELARGONIUM GRAVEOLENS WHOLE (UNII: 0E553RP62F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61077-121-11	11 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	11/06/2013
2	NDC: 61077-121-33	33 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	11/06/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/06/2013

Labeler - Healing Natural Oils LLC (113679703)

Establishment
Name	Address	ID/FEI	Business Operations
King Bio Inc		617901350	manufacture(61077-121)