Label: CALENDULA- calendula officinalis flowering top gel
- NDC Code(s): 0220-1105-54
- 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.
Drug Label Information
Updated February 22, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- QUESTIONS
-
SPL UNCLASSIFIED SECTION
do not use if glued carton end flaps are open or if the tube seal is broken
store at 68-77 o F (20-25 o C)
Skin Irritations*
Rashes Razor Burn Insect Bites*
For all ages
1.5 oz (45 g)
*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.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CALENDULA
calendula officinalis flowering top gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-1105 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 ALCOHOL (UNII: 3K9958V90M) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBIC ACID (UNII: X045WJ989B) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-1105-54 45 g in 1 TUBE; Type 0: Not a Combination Product 09/30/1993 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/30/1993 Labeler - Laboratoires Boiron (282560473) Registrant - Boiron Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-1105)