ARNICA PLUS- 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.

Bruises, strains.

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

USES

This homeopathic medicine helps relieve symptoms associated with:

- minor bruises

- strains

- sprains.

WARNINGS


For external use only.

Do not use if tube seal is broken and 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.

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

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

Repeat 3 times a day or as needed.

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

ARNICA PLUS 
arnica montana, hypericum perforatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-9082
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
WATER (UNII: 059QF0KO0R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PEG-20 GLYCERYL STEARATE (UNII: MJV0165YY8)  
CETEARETH-12 (UNII: 7V4MR24V5P)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
GLYCERYL COCOATE (UNII: WVK1CT5994)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60512-9082-11 in 1 CARTON06/01/2011
150 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/01/2011
Labeler - HOMEOLAB USA INC (202032533)
Establishment
NameAddressID/FEIBusiness Operations
HOMEOLAB USA INC202032533manufacture(60512-9082)

Revised: 12/2018
Document Id: 3a0faf37-3751-40d8-a344-556b857a441e
Set id: 11f8b4ac-b8d9-471c-a066-ab0bf9bfa1e4
Version: 5
Effective Time: 20181214
 
HOMEOLAB USA INC