Calendula by Laboratoires Boiron / Boiron Inc. Calendula Lotion

Calendula by

Drug Labeling and Warnings

Calendula by is a Homeopathic medication manufactured, distributed, or labeled by Laboratoires Boiron, Boiron Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CALENDULA- calendula officinalis flowering top lotion 
Laboratoires Boiron

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.

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Calendula Lotion

Calendula officinalis 1X

Hand and body lotion
Helps promote healing of sunburn and skin irritations (rashes, redness, etc)
Soothes dry skin
Fluid in texture, this moiturizing lotion is quickly absorbed and gives your skin a naturally gentle and confortable feeling.


Shake well before using. For sunburns, clean affected area with water and apply lotion 2 or 3 time a day. For skin irritations and dry skin, apply topically as needed.

Alcohol, caprylyl glycol, carbomer, dimethicone EDTA disodium, octyldodecyl myristate, PEG-6 stearate, PEG-32 stearate, purified water, sodium hydroxide, sorbic acid, stearic acid, 1,2-hexanediol

6.7 OZ (200ml)

Calendula officinalis 1X ... Healing agent HPUS 10 %

Store at 68-77 O F (20-25 O C)

Questions, Comments?
www.boironusa.com
info@boironusa.com
1-800-BOIRON-1 (1-800-264-7661)
Distributed by Boiron Inc.
6 Campus Boulevard
Newtown Square, PA 19073-3267

Consult a doctor in case of deep wounds or serious burns.

Stop use and ask doctor if condition persists for more than 3 days or worsens.

Keep out of reach of children

Moisturizing - Paraben Free - Ideal for soothing Large areas - Works naturally with your body

For external use only
Avoid contact with eyes.
If swallowed, get medical help or contact a Poison Control Center right away.
This product does not contain SPF

bottle

CALENDULA 
calendula officinalis flowering top lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0220-1106
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBIC ACID (UNII: X045WJ989B)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
ALCOHOL (UNII: 3K9958V90M)  
BENZYL STEARATE (UNII: 78032NV0EG)  
PEG-6 STEARATE (UNII: 8LQC57C6B0)  
PEG-32 STEARATE (UNII: 33GX5WQC0M)  
OCTYLDODECYL MYRISTATE (UNII: S013N99GR8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0220-1106-57200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/30/199312/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/30/199312/31/2018
Labeler - Laboratoires Boiron (282560473)
Registrant - Boiron Inc. (014892269)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoires Boiron282560473manufacture(0220-1106)

Revised: 2/2020
Document Id: 9f6a0cd3-82c6-37bc-e053-2995a90a409d
Set id: 3810c8f5-6110-4371-9fbf-2b30ff187fe4
Version: 4
Effective Time: 20200225
 
Laboratoires Boiron