KIDS RELIEF ARNICA- arnica montana, 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, muscle aches

Bruises, strains

These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

The letters "HPUS" indicate that the ingredients in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

USES

This homeopathic medecine is made from a combination of ingredients traditionally used to help relieve symptoms associated with:

- minor bruises

- strains

- sprains

- muscle aches

WARNINGS


For external use only.

Do not use on broken skin.

When using this product, avoid contact with eyes; if contact occurs, rinse abundantly with water to remove.

Stop use and ask a doctor

- if symptoms persist for more than 3 days or worsen

- if hypersensitivity and/or allergy occurs.

Keep out of reach of children. If ingested, get medical help or contact a Poison Control Center immediately.

DIRECTIONS

- Apply a thin layer to the affected area, rub in gently. Repeat 3 times a day or as needed.

- Children under 2 yrs: ask a doctor.

OTHER INFORMATION

- Store at room temperature (68 - 77°F)

- Do not use if tube seal is broken.

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 DRUGItem Code (Source)NDC:60512-9086
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]  in 50 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM1 [hp_X]  in 50 g
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)  
CETEARETH-12 (UNII: 7V4MR24V5P)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL COCOATE (UNII: WVK1CT5994)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
PEG-20 GLYCERYL STEARATE (UNII: MJV0165YY8)  
PEG-100 STEARATE (UNII: YD01N1999R)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60512-9086-11 in 1 CARTON
150 g in 1 TUBE
2NDC:60512-9086-26 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(60512-9086)

Revised: 2/2014
Document Id: 46668cbd-c581-4c65-94a8-4e19b5b041ef
Set id: e2147c5d-8317-4223-8a23-c1c7df86448e
Version: 2
Effective Time: 20140220
 
HOMEOLAB USA INC