REAL TIME PAIN RELIEF HEMP OIL PLUS- arnica montana cream

Real Time Pain Relief Hemp Oil Plus by

Drug Labeling and Warnings

Real Time Pain Relief Hemp Oil Plus 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, Tocopheryl Acetate, Emu Oil, Butylene Glycol, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Phenoxyethanol, Caprylyl Glycol, Carbomer, Triethanolamine, Fragrance, Glycerin, Curcuma Longa (Tumeric) Root Extract, Wasabi Japonica Root Extract, Salix Alba (Willow) Bark Extract, Mentha Piperita (Peppermint) Leaf Oil, Industrial Hemp Seed Oil, Menthol, Extracts of: (Calendula officinalis (Marigold), Anthemis nobilis (Roman Chamomile), Tilia cordata (Lime Tree), Centaurea cyanus (Cornflower), Chamomilla recutita (Matricaria Chamomilla), Hypericum perforatum (St. John’s Wort)), Coriandrum Sativum (Coriander) Fruit Oil.

Principal Display Panel and Drug Facts

INGREDIENTS AND APPEARANCE

REAL TIME PAIN RELIEF HEMP OIL PLUS 
arnica montana cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58133-101
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 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHANOLAMINE LAURYLAMINOPROPIONATE (UNII: 793J74ICPW)
CURCUMA LONGA LEAF (UNII: H2HC4RY52C)
WASABI ROOT (UNII: 69JM5DKE22)
MENTHA PIPERITA LEAF (UNII: A389O33LX6)
TILIA CORDATA FLOWER (UNII: CFN6G1F6YK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
SORBITOL (UNII: 506T60A25R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
EMU OIL (UNII: 344821WD61)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER 940 (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
SALIX ALBA BARK (UNII: 205MXS71H7)
MENTHOL (UNII: L7T10EIP3A)
CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)
ANTHEMIS ARVENSIS FLOWERING TOP (UNII: 851IP1R9YK)
HEMP (UNII: TD1MUT01Q7)
CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)
HYPERICUM PERFORATUM LEAF (UNII: DOC7OB843Y)
CORIANDRUM SATIVUM WHOLE (UNII: 740M8BF6EF)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58133-101-04	114 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2015
2	NDC: 58133-101-12	340 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	01/01/2015
3	NDC: 58133-101-15	42 g in 1 TUBE; 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(58133-101)