REAL TIME PAIN RELIEF HEMP OIL PLUS- arnica montana cream 
Cosmetic Specialty Labs, 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.

----------

Real Time Pain Relief Hemp Oil Plus

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:

Stop use and ask a doctor if:

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

Labeling

REAL TIME PAIN RELIEF HEMP OIL PLUS 
arnica montana cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA3 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-101-04114 g in 1 TUBE; Type 0: Not a Combination Product01/01/2015
2NDC:58133-101-12340 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/2015
3NDC:58133-101-1542 g in 1 TUBE; Type 0: Not a Combination Product01/01/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/01/2015
Labeler - Cosmetic Specialty Labs, Inc. (032973000)
Registrant - Cosmetic Specialty Labs, Inc. (032973000)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Specialty Labs, Inc.032973000manufacture(58133-101)

Revised: 1/2018
Document Id: 62d7422a-1d5b-164f-e053-2a91aa0acec7
Set id: 62d7422a-1d5a-164f-e053-2a91aa0acec7
Version: 1
Effective Time: 20180115
 
Cosmetic Specialty Labs, Inc.