ACTIVE INGREDIENTS HPUS

Calendula officinalis (Marigold) 1X
Echinacea angustifolia (Coneflower) 1X
Hypericum perforatum (St John's wort) 3X
Phytolacca decandra (American nightshade) 3X
Cantharis (Spanish fly) 3X
Sulphur (Sulfur) 3X

PURPOSE

Cuts, burns
Itching skin
Scrapes, scars
Itchy dry skin
Burning pain
Chapped rough skin

The letters HPUS indicate the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

USES

This homeopathic medicine helps:

- promote healing of minor cuts, scrapes, scars and burns

- soften itchy dry, rough or chapped skin.

WARNINGS

For external use only.

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

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 hypersensibility and/or allergy occurs.

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

DIRECTIONS

Clean affected area and apply a thin layer 3 times a day or as needed. May be covered with a sterile bandage.

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 FIRST AID WITH CALENDULA
calendula officinalis, echinacea angustifolia, hypericum perforatum, phytolacca decandra, cantharis, sulphur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59779-192
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X] in 50 g
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8)	ECHINACEA ANGUSTIFOLIA	1 [hp_X] in 50 g
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	3 [hp_X] in 50 g
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	3 [hp_X] in 50 g
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT)	LYTTA VESICATORIA	3 [hp_X] in 50 g
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	3 [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)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59779-192-01	50 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		12/07/2012

Labeler - CVS PHARMACY (062312574)

Registrant - HOMEOLAB USA INC (202032533)

Name	Address	ID/FEI	Business Operations
Establishment
HOMEOLAB USA INC		202032533	manufacture(59779-192)

DRUG FACTS