KIDS RELIEF ARNICA - arnica montana and hypericum perforatum 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

Arnica montana (Leopard's bane) 1X
Hypericum perforatum (St John's Wort) 1X

PURPOSE

Pain, bruises, sprains

Bruises, strains

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

USES

This homeopathic medecine helps relieve symptoms associated with:

- minor bruises

- strains

- sprains.

WARNINGS


For external use only.

Do not use

- if tube seal is broken

- on broken skin.

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

Apply a thin layer to the affected area, rub in gently.

Repeat 3 times a day or as needed.


0-9 yrs: Apply thin layer to affected area and rub

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 ARNICA 
arnica montana, hypericum perforatum cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:60512-9086
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA1 [hp_X]  in 50 g
HYPERICUM PERFORATUM (HYPERICUM PERFORATUM) HYPERICUM PERFORATUM1 [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:60512-9086-11 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: b8a2d78e-094d-487a-82d9-ef6be9c7eebe
Set id: e2147c5d-8317-4223-8a23-c1c7df86448e
Version: 1
Effective Time: 20120315
 
HOMEOLAB USA INC