CALENDULA PLUS  - calendula officinalis flowering top, echinacea angustifolia, hypericum perforatum, phytolacca americana root, lytta vesicatoria and sulfur cream 
HOMEOLAB USA INC

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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ACTIVE INGREDIENTS HPUS

Calendula officinalis (Marigold) 1X

Echinacea angustifolia (Coneflower) 1X

Hypericum perforatum (St John`s wort) 3X

Phytolacca decandra (American nightshade) 3X

Cantharis (Spanish fly) 3X

Sulphur (Sulfur) 3X

PURPOSE

Wounds, burns.

Itching skin.

Painful scars.

Itchy dry skin.

Burning pain.

Chapped rough skin.

The letters HPUS indicate that these ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.

USES

This homeopathic medicine helps:

- promote healing of minor cuts, scrapes or burns

- soften dry, rough or chapped skin.

WARNINGS


For external use only.

Do not use if tube seal is broken.

When using this product, avoid contact with eyes.

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Clean affected area and apply a thin layer 3 times a day or as needed. May be covered with a sterile bandage.

OTHER INFORMATION

Store at room temperature (68-77F).

INACTIVE INGREDIENTS

Carbomer, ceteareth-12, cetearyl alcohol, cetyl alcohol, cetyl palmitate, DMDM hydantoin, glycerin, glyceryl cocoate, glyceryl stearate, iodopropynyl butylcarbamate, isopropyl myristate, isopropyl palmitate, octyldodecanol, PEG-20 glyceryl stearate, PEG-100 stearate, purified water, sodium hydroxide, sorbitan stearate.

CARTON

image of carton label


CALENDULA PLUS 
calendula officinalis, echinacea, hypericum perforatum, phytolacca decandra, cantharis, sulphur cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-0050
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALENDULA OFFICINALIS FLOWERING TOP (CALENDULA OFFICINALIS FLOWERING TOP) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 50 g
ECHINACEA ANGUSTIFOLIA (ECHINACEA ANGUSTIFOLIA) ECHINACEA ANGUSTIFOLIA1 [hp_X]  in 50 g
HYPERICUM PERFORATUM (HYPERICUM PERFORATUM) HYPERICUM PERFORATUM3 [hp_X]  in 50 g
PHYTOLACCA AMERICANA ROOT (PHYTOLACCA AMERICANA ROOT) PHYTOLACCA AMERICANA ROOT3 [hp_X]  in 50 g
LYTTA VESICATORIA (LYTTA VESICATORIA) LYTTA VESICATORIA3 [hp_X]  in 50 g
SULFUR (SULFUR) SULFUR3 [hp_X]  in 50 g
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERYL MONOSTEARATE 
OCTYLDODECANOL 
ISOPROPYL PALMITATE 
ISOPROPYL MYRISTATE 
PEG-20 GLYCERYL STEARATE 
CETEARETH-12 
CETYL PALMITATE 
GLYCERYL COCOATE 
CETOSTEARYL ALCOHOL 
SORBITAN MONOSTEARATE 
CETYL ALCOHOL 
GLYCERIN 
POLYOXYL 100 STEARATE 
DMDM HYDANTOIN 
IODOPROPYNYL BUTYLCARBAMATE 
CARBOMER HOMOPOLYMER TYPE A 
SODIUM HYDROXIDE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:60512-0050-11 TUBE ( TUBE) in 1 CARTONcontains a TUBE
150 g in 1 TUBEThis package is contained within the CARTON (60512-0050-1)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/26/1997

Labeler - HOMEOLAB USA INC (202032533)
Establishment
NameAddressID/FEIOperations
HOMEOLAB USA INC202032533manufacture

Revised: 11/2011 HOMEOLAB USA INC