FIRST AID PAIN AND TRAUMA 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 (SIMILAX REGELII) 30X

INDICATIONS:

May temporarily relieve pain due to inflammation caused by but not limited to the following: cuts and scrapes, burns including sunburn, abrasions, bruising**

**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 pregnant or breast-feeding, ask a health professional 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: cuts and scrapes, burns including sunburn, abrasions, brusing**

**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), INSTANTIZED SOLUBLE EGGSHELL MEMBRANE + (BIOVADERM BRAND WITH 1% SUNFLOWER LECITHIN), 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)*

*EXTRACT

QUESTIONS:

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

PACKAGE LABEL DISPLAY:

peaceful mountain

THE HEIGHT OF HEALTH

first aid pain &

trauma relief

homeopathic spray

1 fl. oz. (30 mL)

first aid pain and trauma relief

FIRST AID PAIN AND TRAUMA 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:43846-0045
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_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
SARSAPARILLA (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG)	SARSAPARILLA	30 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
LARREA TRIDENTATA TOP (UNII: PK0TXD049P)
COMFREY LEAF (UNII: DG4F8T839X)
CROTON LECHLERI RESIN (UNII: GGG6W25C63)
EGG SHELL MEMBRANE (UNII: N7QBR4212V)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
SILVER (UNII: 3M4G523W1G)
MELISSA OFFICINALIS (UNII: YF70189L0N)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43846-0045-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/30/2014	01/19/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		12/30/2014	01/19/2023

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43846-0045) , api manufacture(43846-0045) , label(43846-0045) , pack(43846-0045)

Revised: 12/2021

Document Id: 19587dc1-1247-452d-8ed1-8a92b06de8be

Set id: 54b03761-c746-4069-9e4b-b26d863d28a6

Version: 3

Effective Time: 20211214

Peaceful Mountain, Inc.