Pain Away Solution (Aconitum Nepellus Hypericum Peforatum Lycopodium Clavatum Phosphorus Rhus Toxicodendron Secale Cornutum) Spray [Pure Source, Llc] -

PAIN AWAY SOLUTION (ACONITUM NEPELLUS HYPERICUM PEFORATUM LYCOPODIUM CLAVATUM PHOSPHORUS RHUS TOXICODENDRON SECALE CORNUTUM) SPRAY [PURE SOURCE, LLC]
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NDC	65121-887-01, 65121-887-02, 65121-887-03
Set ID	579b1f76-1297-684f-e053-2a91aa0a83d7
Category	HUMAN OTC DRUG LABEL
Packager	Pure Source, LLC
Generic Name
Product Class
Product Number
Application Number

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ACTIVE INGREDIENT

Aconitum Napellus, 24X HPUS

Hypericum Peforatum, 24X HPUS

Lycopodium Clavatum, 24X HPUS

Phosphorus, 24X HPUS

Rhus Toxicodendron, 24X HPUS

Secale Cornuum, 24X HPUS
PURPOSE

Nerve Pain Relief
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 - (800-222-1222)
INDICATIONS & USAGE

Use

For the temporary relief of nerve pain
WARNINGS
Warnings

For external use only.

Do not use on wounds or damaged skin.

Stop use and ask doctor if
- Symptoms persist for more than seven days.
- If irritation occurs, discontinue use.
When using this product
- Avoid contact with eyes.
- Do not wrap treated area with bandage.
If pregnant or breast feeding, ask a health professional before use.
DOSAGE & ADMINISTRATION
Directions
- Spray small amount to cover the affected area.
- Do not apply more than 4 times daily.
- Avoid contact with eyes and mucus membranes.
INACTIVE INGREDIENT

Inactive Ingredients

Bergamot Oil, Cassia Leaf Oil, Eucalyptus Oil, Geranium Oil, Histamine Dihydrochloride, Lavender Oil, Safflower Oil, SD-Alcohol 38B, Tea Tree Oil
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN AWAY SOLUTION
aconitum nepellus hypericum peforatum lycopodium clavatum phosphorus rhus toxicodendron secale cornutum spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65121-887
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	24 [hp_X] in 100 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	24 [hp_X] in 100 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	24 [hp_X] in 100 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	24 [hp_X] in 100 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	24 [hp_X] in 100 mL
CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N)	CLAVICEPS PURPUREA SCLEROTIUM	24 [hp_X] in 100 mL

Ingredient Name	Strength
Inactive Ingredients
EUCALYPTUS OIL (UNII: 2R04ONI662)
LAVENDER OIL (UNII: ZBP1YXW0H8)
TEA TREE OIL (UNII: VIF565UC2G)
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
CHINESE CINNAMON LEAF OIL (UNII: 4U4V2F2E4Y)
BERGAMOT OIL (UNII: 39W1PKE3JI)
SAFFLOWER OIL (UNII: 65UEH262IS)
HISTIDINE MONOHYDROCHLORIDE (UNII: 1D5Q932XM6)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65121-887-01	10 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	08/25/2017
2	NDC:65121-887-02	15 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	08/25/2017
3	NDC:65121-887-03	15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/25/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/25/2017

Labeler - Pure Source, LLC (080354456)

Name	Address	ID/FEI	Business Operations
Establishment
Pure Source, LLC		080354456	manufacture(65121-887)

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Medic

PAIN AWAY SOLUTION (ACONITUM NEPELLUS HYPERICUM PEFORATUM LYCOPODIUM CLAVATUM PHOSPHORUS RHUS TOXICODENDRON SECALE CORNUTUM) SPRAY [PURE SOURCE, LLC]

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