Label: REAL TIME PAIN RELIEF HEMP OIL PLUS- arnica montana cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58133-101-04, 58133-101-12, 58133-101-15 - Packager: Cosmetic Specialty Labs, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated January 15, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses:
- Warnings:
- When using this product:
- Stop use and ask a doctor if:
- KEEP OUT OF REACH OF CHILDREN
- Directions:
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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
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INGREDIENTS AND APPEARANCE
REAL TIME PAIN RELIEF HEMP OIL PLUS
arnica montana creamProduct 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)