KIDS PAIN RELIEF WITH ARNICA- arnica montana, hypericum perforatum cream 
CVS PHARMACY

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

The letters HPUS indicate the 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

- muscle pains.

WARNINGS


For external use only.

Do not use if tube foil seal is broken or missing.

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 right away.

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 - 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

KIDS PAIN RELIEF  WITH ARNICA
arnica montana, hypericum perforatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-191
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)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-191-0150 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic12/07/2012
Labeler - CVS PHARMACY (062312574)
Registrant - HOMEOLAB USA INC (202032533)
Establishment
NameAddressID/FEIBusiness Operations
HOMEOLAB USA INC202032533manufacture(59779-191)

Revised: 12/2012
Document Id: ed2837f3-6cff-43ea-a007-ab7a07ebfaf7
Set id: c473d34f-7d78-4a66-ac91-a25bb46dbd1c
Version: 2
Effective Time: 20121219
 
CVS PHARMACY