Label: BM CALENDULA OFFICINALIS- calendula officinalis spray
- NDC Code(s): 85816-6018-1
- Packager: BM 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 June 27, 2025
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- PURPOSE
- CONTRAINDICATIONS
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BM CALENDULA OFFICINALIS
calendula officinalis sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:85816-6018 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 0.527 mL in 1 mL ALCOHOL (UNII: 3K9958V90M) 0.473 mL in 1 mL Product Characteristics Color yellow (brownish yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:85816-6018-1 30 mL in 1 BOTTLE, SPRAY; 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 - BM Private Limited (645599762) Establishment Name Address ID/FEI Business Operations BM Private Limited 645599762 manufacture(85816-6018)
