KIDS RELIEF CALENDULA - 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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DRUG FACTS

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 the ingredients are officially included in the Homeopathic Pharmacopoeia of the United States.

USES

This homeopathic medecine 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.

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.


0-9 yrs: Clean affected area and apply a thin layer

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

TUBE

image of tube label

KIDS RELIEF CALENDULA 
calendula officinalis, echinacea angustifolia, hypericum perforatum, phytolacca decandra, cantharis, sulphur cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:60512-9087
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
CARBOMER HOMOPOLYMER TYPE A 
CETEARETH-12 
CETOSTEARYL ALCOHOL 
CETYL ALCOHOL 
CETYL PALMITATE 
DMDM HYDANTOIN 
GLYCERIN 
GLYCERYL COCOATE 
GLYCERYL MONOSTEARATE 
IODOPROPYNYL BUTYLCARBAMATE 
ISOPROPYL MYRISTATE 
ISOPROPYL PALMITATE 
OCTYLDODECANOL 
PEG-20 GLYCERYL STEARATE 
PEG-100 STEARATE 
WATER 
SODIUM HYDROXIDE 
SORBITAN MONOSTEARATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60512-9087-11 in 1 CARTON
150 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/15/2012
Labeler - HOMEOLAB USA INC (202032533)
Establishment
NameAddressID/FEIBusiness Operations
HOMEOLAB USA INC202032533manufacture

Revised: 3/2012
Document Id: 3ecf3f26-5c27-4916-a88f-6c16923a8a89
Set id: 46828c9d-0852-48d8-917b-ef85e0563094
Version: 1
Effective Time: 20120315
 
HOMEOLAB USA INC