Label: ARNICA- arnica montana ointment
- NDC Code(s): 82797-111-20
- Packager: Dr. Masood Homeopathic Pharmaceuticals(Private) Limited
- 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 9, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DOSAGE & ADMINISTRATION
-
WARNINGS
For external use only
Do not:
- use if you have an allergy or hypersensitivity to components of the formula
- apply to wounds or damaged skin
- apply to children under two years of age
When using this product:
- avoid contact with eyes
- do not bandage tightly
- apply over large areas of the body
Stop use and ask a doctor if:
- condition worsens
- If symptoms persists for more than 7 days or clear up and again within a few days
- rash develops
If swallowed get medical help of contact a Poison Control Center right away.
- INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- PURPOSE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ARNICA
arnica montana ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82797-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ) ARNICA MONTANA FLOWER 2 g in 20 g Inactive Ingredients Ingredient Name Strength CARBOMER 980 (UNII: 4Q93RCW27E) 0.2 g in 20 g SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.03 g in 20 g WATER (UNII: 059QF0KO0R) 20 g in 20 g WHITE PETROLATUM (UNII: B6E5W8RQJ4) 1 g in 20 g Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82797-111-20 20 in 1 BOX 12/01/2022 1 20 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/01/2022 Labeler - Dr. Masood Homeopathic Pharmaceuticals(Private) Limited (645453119) Registrant - Dr. Masood Homeopathic Pharmaceuticals ( Private) Limited (645453119) Establishment Name Address ID/FEI Business Operations Dr. Masood Homeopathic Pharmaceuticals (Private) Limited 645453119 manufacture(82797-111) , pack(82797-111) , label(82797-111)
