NDC | 58133-300-04, 58133-300-12, 58133-300-15 |
Set ID | 61e590d9-f6f4-bf71-e053-2991aa0a534d |
Category | HUMAN OTC DRUG LABEL |
Packager | Cosmetic Specialty Labs, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- 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)