Label: CALENDULA- calendula officinalis flowering top ointment
- NDC Code(s): 0220-1104-51
- Packager: Laboratoires Boiron
- 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.
Updated September 29, 2020
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- DO NOT USE
DOSAGE & ADMINISTRATION
For minor burns, immediately run cool water on the burn for several minutes and pat dry. Then apply a thin layer of Calendula Ointment to affected area 3 times a day or as needed.
For cuts, scrapes, and chapped skin, first cleanse the area with mild soap, rinse and dry. Then apply a thin layer of Calendula Ointment to affected area 3 times a day or as needed.
- INACTIVE INGREDIENT
- HOW SUPPLIED
- STORAGE AND HANDLING
- ASK DOCTOR
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- WHEN USING
- DRUG INTERACTIONS
SPL UNCLASSIFIED SECTION
†Homeopathic mother tincture made from Calendula officinalis flowering tops.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
Soothes & Heals
Cuts, Scrapes, Minor Burns, Chapped Skin*
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
calendula officinalis flowering top ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-1104 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 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-1104-51 30 g in 1 TUBE; Type 0: Not a Combination Product 07/17/1988 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/17/1988 Labeler - Laboratoires Boiron (282560473) Registrant - Boiron Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-1104)