SHINGLES PAIN ULCERATION RELIEF (calendula officinalis, croton tiglium, natrum muriaticum, plantago major, rhus tox, sarsaparilla- smilax regelii spray

Shingles Pain Ulceration Relief by

Drug Labeling and Warnings

Shingles Pain Ulceration Relief by is a Homeopathic medication manufactured, distributed, or labeled by Peaceful Mountain, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Calendula Officinalis 12X, Croton Tiglium 30X, Natrum Muriaticum 30X, Plantago Major 30X, Rhus Tox 30X, Sarsaparilla (Smilax Regelii) 30X.

INDICATIONS:

May temporarily relieve pain due to inflammation caused by but not limited to the following: itching and sensitivity, eruptions, blisters.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

For external use only

If symptoms persist, consult a doctor.

If pregnant or breast feeding, ask a doctor before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not get into eyes.

If symptoms persist, consult a doctor.

Do not use if tamper evident seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Spray liberally on affected area as needed. Consult a physician for use in children under 12 years of age.

INDICATIONS:

May temporarily relieve pain due to inflammation caused by but not limited to the following: itching and sensitivity, eruptions, blisters.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

Aloe Barbadensis Leaf Juice (Aloe Vera 10x Concentrate), Arnica Montana (Flower), Larrea Tridentata (Leaf), Symphytum Officinale (Leaf), Croton Lechleri (Sap), Lavandula Angustifolia (Buds), Ionic Colloidal Silver, Melissa Officinalis (Leaf), [Peg-33, Peg-8 Dimethicone, Peg-14 (Silsense Copolyol-1 Silicone)], [Phenoxyethanol, Caprylyl Glycol, Sorbic Acid (Optiphen-Plus)], Phytolacca Americana (Berries), Phytolacca Americana (Root), Potassium Sorbate, Purified Water, Sodium Bicarbonate, Hypericum Perforatum (Aerial Parts), Tocopherol [Vitamin E Oil](Derived From Soy Bean), Vitamin C Powder (Ascorbic Acid), Whey Protein Concentrate, Salix Alba (Bark), Achillea Millefolium (Flower)

QUESTIONS:

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

PACKAGE LABEL DISPLAY:

peaceful mountain

THE HEIGHT OF HEALTH

shingles pain &

ulceration relief

homeopathic spray

1 fl. oz. (30 mL)

INGREDIENTS AND APPEARANCE

SHINGLES PAIN ULCERATION RELIEF 
calendula officinalis, croton tiglium, natrum muriaticum, plantago major, rhus tox, sarsaparilla (smilax regelii) spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43846-0056
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	12 [hp_X]  in 1 mL
CROTON TIGLIUM SEED (UNII: 0HK2GZK66E) (CROTON TIGLIUM SEED - UNII:0HK2GZK66E)	CROTON TIGLIUM SEED	30 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	30 [hp_X]  in 1 mL
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U)	PLANTAGO MAJOR	30 [hp_X]  in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	30 [hp_X]  in 1 mL
SMILAX REGELII ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG)	SMILAX REGELII ROOT	30 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA (UNII: O80TY208ZW)
LARREA TRIDENTATA TOP (UNII: PK0TXD049P)
COMFREY LEAF (UNII: DG4F8T839X)
CROTON LECHLERI RESIN (UNII: GGG6W25C63)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
SILVER (UNII: 3M4G523W1G)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
PHYTOLACCA AMERICANA FRUIT (UNII: WE63661499)
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
WHEY (UNII: 8617Z5FMF6)
SALIX ALBA BARK (UNII: 205MXS71H7)
ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43846-0056-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/25/2015	11/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/25/2015	11/12/2020

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43846-0056) , api manufacture(43846-0056) , label(43846-0056) , pack(43846-0056)