Label: REAL TIME PAIN RELIEF SELECT PLUS HEMP OIL- arnica montana lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58133-800-03 - Packager: Cosmetic Specialty Labs, Inc.
- Category: HUMAN OTC DRUG LABEL
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
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- 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, 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
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INGREDIENTS AND APPEARANCE
REAL TIME PAIN RELIEF SELECT PLUS HEMP OIL
arnica montana lotionProduct 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)