REAL TIME PAIN RELIEF SELECT PLUS HEMP OIL- arnica montana lotion

Real Time Pain Relief Select Plus Hemp Oil by

Drug Labeling and Warnings

Real Time Pain Relief Select Plus Hemp Oil by is a Homeopathic medication manufactured, distributed, or labeled by Cosmetic Specialty Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Arnica Montana (3X H.P.U.S.)

Purpose

Bruising, Stiffness, Pain

*The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Uses

Temporarily relieves symptoms of muscle pain, soreness, bruising and swelling due to overexertion or injury.

Warnings

for external use only

When using this product

• avoid contact with eyes
• If swallowed, get medical help or contact a Poison Control Center immediately.
• Test for allergy by rubbing small amount on skin first.
• Do not use if allergic to or hypersensitive to any ingredient.
• If condition worsens or does not improve consult a doctor.

Stop use and ask a doctor if:

• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days
• redness is present
• irritation develops

KEEP OUT OF REACH OF CHILDREN

Keep all medicines out of reach of children.

Directions:

Apply to affected area 2 times daily or as needed.

Other Ingredients:

Aloe Barbadensis Leaf Juice, Purified Water, Methylsulfonylmethane, Sorbitol, Cetearyl Alcohol, Cetyl Alcohol, SD Alcohol 40, Butylene Glycol, Hamamelic Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Rubus Idaeus (Raspberry) Seed Oil, Phenoxyethanol, Caprylyl Glycol, Fragrance, Carbomer, Triethanolamine, Salix Alba (Willow) Bark Extract, Industrial Hemp Seed Oil, Menthol, Capsicum Frutescens Fruit, Calendula officinalis (Marigold), Anthemis nobilis (Roman Chamomile), Tilia cordata (Lime Tree), Centaurea cyanus (Cornflower), Chamomilla recueta (Matricaria Chamomilla), Hypericum perforatum (St. John’s Wort), Coriandrum Saevum (Coriander) Fruit Oil.

SPL UNCLASSIFIED SECTION

There is no scientific evidence that homeopathic products work. The product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.

100% VEGAN

Principal Display Panel and Drug Facts

INGREDIENTS AND APPEARANCE

REAL TIME PAIN RELIEF SELECT PLUS HEMP OIL 
arnica montana lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58133-800
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	3 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE) (UNII: 36YHT392ID)
CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)
CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
CETYL ALCOHOL (UNII: 936JST6JCN)
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)
RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER 940 (UNII: 4Q93RCW27E)
SALIX ALBA BARK (UNII: 205MXS71H7)
HEMP (UNII: TD1MUT01Q7)
CAPSICUM FRUTESCENS WHOLE (UNII: 6XJX33L87P)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MENTHOL (UNII: L7T10EIP3A)
CHAMOMILE (UNII: FGL3685T2X)
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
CORIANDRUM SATIVUM WHOLE (UNII: 740M8BF6EF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-800-03	88 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product	01/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2015

Labeler - Cosmetic Specialty Labs, Inc. (032973000)

Registrant - Cosmetic Specialty Labs, Inc. (032973000)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Specialty Labs, Inc.		032973000	manufacture(58133-800)