Muscle/tendon Pain And Stress Relief (Calendula Officinalis, Croton Tiglium, Natrum Muriaticum, Plantago Major, Rhus Tox, Sarsaparilla (Smilax Regelii)) Spray [Liddell Laboratories, Inc.] -

MUSCLE/TENDON PAIN AND STRESS RELIEF (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [LIDDELL LABORATORIES, INC.]
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NDC	50845-0223-1
Set ID	74d165f4-235c-42c7-a7d8-e78d16ace8d7
Category	HUMAN OTC DRUG LABEL
Packager	Liddell Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number

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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: cramping and spasms, pulls and tears, stress and strains.**

**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.

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:

Adults and children over 12: Spray liberally on affected area as needed. Children 12 and under: Consult a doctor prior to use.
INDICATIONS:

May temporarily relieve pain due to inflammation caused by but not limited to the following: cramping and spasms, pulls and tears, stress and strains.**

**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 Base, 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 LIDDELL LABORATORIES, INC. WOODBINE, IA
51579 WWW.LIDDELL.NET 1-800-460-7733
PACKAGE LABEL DISPLAY:

ORAL SPRAYS

LIDDELL

LABORATORIES

EST. 1994

Muscle/Tendon

Pain & Stress

Relief

TOPICAL HOMEOPATHIC SPRAY

1.0 FL OZ. (30 ml)

INGREDIENTS AND APPEARANCE

MUSCLE/TENDON PAIN AND STRESS 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:50845-0223
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
SMILAX REGELII ROOT (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG)	SMILAX REGELII ROOT	30 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50845-0223-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		12/04/2015

Labeler - Liddell Laboratories, Inc. (832264241)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(50845-0223) , api manufacture(50845-0223) , label(50845-0223) , pack(50845-0223)

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Medic

MUSCLE/TENDON PAIN AND STRESS RELIEF (CALENDULA OFFICINALIS, CROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLA (SMILAX REGELII)) SPRAY [LIDDELL LABORATORIES, INC.]

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