Label: REAL TIME PAIN RELIEF DAILY RELIEF (arnica montana- 2x h.p.u.s. lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 58133-300-04, 58133-300-12, 58133-300-15 - 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 3, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses:
- Warnings
- When using this product
- Warnings and Precautions
- Stop use and ask a doctor
- KEEP OUT OF REACH OF CHILDREN
- Directions
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Other Ingredients
Purified Water, Methylsulfonylmethane, Sorbitol, Cetearyl Alcohol, SD Alcohol40, Cetyl Alcohol, Carbomer, Butylene Glycol, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Emu Oil, Phenoxyethanol, Caprylyl Glycol, Triethanolamine, Gycerin, Myristica Fragrans (Nutmeg) Extract, Fragrance, Diazolidinyl Urea, Salix Alba (Willow) Bark Extract, Aloe Barbadensis Leaf Juice, Menthol, Extracts of: (Calendula officianlis (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.
- Package Label, Principal Display Panel and Drug Facts
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INGREDIENTS AND APPEARANCE
REAL TIME PAIN RELIEF DAILY RELIEF
arnica montana (2x h.p.u.s.) lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58133-300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 2 mg in 100 mL Inactive Ingredients Ingredient Name Strength EMU OIL (UNII: 344821WD61) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERIN (UNII: PDC6A3C0OX) MYRISTICA FRAGRANS FRUIT (UNII: GOO22BTU71) TILIA CORDATA FLOWER (UNII: CFN6G1F6YK) CENTAUREA CYANUS FLOWER (UNII: QZ239038YC) MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) CORIANDRUM SATIVUM WHOLE (UNII: 740M8BF6EF) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) SORBITOL (UNII: 506T60A25R) SALIX ALBA BARK (UNII: 205MXS71H7) CETYL ALCOHOL (UNII: 936JST6JCN) WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CARBOMER 934 (UNII: Z135WT9208) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CAPRYLYL GLYCOL (UNII: 00YIU5438U) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) ALOE (UNII: V5VD430YW9) MENTHOL (UNII: L7T10EIP3A) CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV) CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9) HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) 2,2-DICHLORO-1-(2-CHLOROPHENYL)ETHANOL (UNII: 1O5KW1KM6N) HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) CLOPYRALID TRIETHANOLAMINE (UNII: O7T195VRMB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58133-300-15 45 mL in 1 TUBE; Type 0: Not a Combination Product 01/31/2014 2 NDC:58133-300-04 120 mL in 1 TUBE; Type 0: Not a Combination Product 01/31/2014 3 NDC:58133-300-12 345 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/31/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/31/2014 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(58133-300)