Kids Relief Arnica (Arnica Montana, Hypericum Perforatum) Cream [Homeolab Usa Inc] -

KIDS RELIEF ARNICA (ARNICA MONTANA, HYPERICUM PERFORATUM) CREAM [HOMEOLAB USA INC]
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NDC	60512-9086-1, 60512-9086-2
Set ID	e2147c5d-8317-4223-8a23-c1c7df86448e
Category	HUMAN OTC DRUG LABEL
Packager	HOMEOLAB USA INC
Generic Name
Product Class
Product Number
Application Number

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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.
REFERENCES

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
TUBE

INGREDIENTS AND APPEARANCE

KIDS RELIEF ARNICA
arnica montana, hypericum perforatum cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60512-9086
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	1 [hp_X] in 50 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	1 [hp_X] in 50 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC:60512-9086-1	1 in 1 CARTON
1		50 g in 1 TUBE
2	NDC:60512-9086-2	6 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/15/2012

Labeler - HOMEOLAB USA INC (202032533)

Name	Address	ID/FEI	Business Operations
Establishment
HOMEOLAB USA INC		202032533	manufacture(60512-9086)

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KIDS RELIEF ARNICA (ARNICA MONTANA, HYPERICUM PERFORATUM) CREAM [HOMEOLAB USA INC]

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