H-Acne Formula (Calendula Officinalis, Nux Vomica, Silicea) Oil [Healing Natural Oils Llc] -

H-ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA) OIL [HEALING NATURAL OILS LLC]
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NDC	61077-020-11, 61077-020-33
Set ID	fd9598ac-8f69-4fba-99c1-4234c8afcafd
Category	HUMAN OTC DRUG LABEL
Packager	Healing Natural Oils LLC
Generic Name
Product Class
Product Number
Application Number

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Active Ingredients:

Calendula officinalis-12C HPUS,
Nux vomica -12C HPUS,
Silicea 12C HPUS

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Purpose

Calendula officinalis -12C HPUS (healing agent),
Nux vomica-12C HPUS (acne, skin red),
Silicea 12C HPUS (for blotches on skin)

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

Inactive Ingredients:

Essential Oil Blend (Cymbopogon martinii aerial parts,
Daucus carota seed, Helichrysum italicum flower,
Lavandula officinalis flower bud, Melaleuca
alternifolia leaf-branch, Pelargonium
graveolens whole plant)

Indications:

For the temporary relief of the symptoms of acne, blemishes and pimples.

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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 finger and apply directly to the affected area 3x per day.
Do not oversaturate or exceed dosage.

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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.

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DESCRIPTION

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

Healing Natural Oils

H-Acne
Formula

Homeopathic

For External Use Only

020

11ml (0.37 fl. oz)
amoils.com

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INGREDIENTS AND APPEARANCE

H-ACNE FORMULA
calendula officinalis, nux vomica, silicea oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61077-020
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	12 [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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	12 [hp_C] in 11 mL

Ingredient Name	Strength
Inactive Ingredients
CYMBOPOGON MARTINI TOP (UNII: 7K1N3UZ6DU)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
DAUCUS CAROTA SUBSP. SATIVUS SEED (UNII: 9M6AAX381U)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)
PELARGONIUM GRAVEOLENS WHOLE (UNII: 0E553RP62F)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:61077-020-11	11 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	11/06/2013
2	NDC:61077-020-33	33 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	11/06/2013

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

Labeler - Healing Natural Oils LLC (113679703)

Name	Address	ID/FEI	Business Operations
Establishment
King Bio Inc.		617901350	manufacture(61077-020)

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Medic

H-ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA) OIL [HEALING NATURAL OILS LLC]

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