SHINGLES PAIN ULCERATION RELIEF- calendula officinalis, croton tiglium, natrum muriaticum, plantago major, rhus tox, sarsaparilla (smilax regelii) spray 
Peaceful Mountain, 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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DRUG FACTS:

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)

Shingles Pain & Ulceration Relief

SHINGLES PAIN ULCERATION RELIEF 
calendula officinalis, croton tiglium, natrum muriaticum, plantago major, rhus tox, sarsaparilla (smilax regelii) spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0056
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 TOP12 [hp_X]  in 1 mL
CROTON TIGLIUM SEED (UNII: 0HK2GZK66E) (CROTON TIGLIUM SEED - UNII:0HK2GZK66E) CROTON TIGLIUM SEED30 [hp_X]  in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE30 [hp_X]  in 1 mL
PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR30 [hp_X]  in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF30 [hp_X]  in 1 mL
SMILAX REGELII ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SMILAX REGELII ROOT30 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43846-0056-130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/25/201511/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic11/25/201511/12/2020
Labeler - Peaceful Mountain, Inc. (078430707)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43846-0056) , api manufacture(43846-0056) , label(43846-0056) , pack(43846-0056)

Revised: 5/2018
 
Peaceful Mountain, Inc.