Label: HOMEOPATHIC LIP BALM- arnica montana ointment
-
Contains inactivated NDC Code(s)
NDC Code(s): 58133-111-01, 58133-111-05 - 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 8, 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
- Stop use and ask a doctor if:
- KEEP OUT OF REACH OF CHILDREN
- Directions
-
Inactive Ingredients
Petrolatum, Synthetic Beeswax, Isopropyl Palmitate, Menthol, Lanolin, Tocopheryl Acetate, Cocos Nucifera (Coconut) Oil, Natural Flavor, Lavandula Angustifolia (Lavender) Oil, Glycerin, Chamomilla Recutita (Matricaria) Flower Extract, Butyrospermum Parkii (Shea) Butter, Mentha Piperita (Peppermint) Leaf Oil, Isopropyl Myristate, Also Barbadensis Leaf Extract, Simmondsia Chinensis (Jojoba) See Oil, Camphor, Butylene Glycol, Stevia Rebaudiana Leaf/Stem Extract.
- Principal Display Panel, Drug Facts
-
INGREDIENTS AND APPEARANCE
HOMEOPATHIC LIP BALM
arnica montana ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58133-111 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 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength CAMPHOR LEAF OIL (UNII: 51D0RGY52V) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) PETROLATUM (UNII: 4T6H12BN9U) LAVANDULA ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L) BUTYROSPERMOL (UNII: 6SF0L0FL42) MENTHA PIPERITA LEAF (UNII: A389O33LX6) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERIN (UNII: PDC6A3C0OX) MENTHOL (UNII: L7T10EIP3A) LANOLIN (UNII: 7EV65EAW6H) ALOE VERA LEAF (UNII: ZY81Z83H0X) SIMMONDSIA CHINENSIS LEAF (UNII: 67G221EK95) COCOS NUCIFERA WHOLE (UNII: 245J88W96L) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099) MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58133-111-05 15 g in 1 JAR; Type 0: Not a Combination Product 01/01/2015 2 NDC:58133-111-01 5.5 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(58133-111)