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

Wounds, burns.

Itching skin.

Painful scars.

Itchy dry skin.

Burning pain.

Chapped rough skin.

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

USES

This homeopathic medicine helps:

- promote healing of minor cuts, scrapes or burns

- soften dry, rough or chapped skin.

WARNINGS

For external use only.

Do not use if tube seal is broken.

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

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

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

TUBE

image of tube label

CALENDULA PLUS
calendula officinalis, echinacea, hypericum perforatum, phytolacca decandra, cantharis, sulphur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60512-0050
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
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:60512-0050-1	1 in 1 CARTON	03/26/1997
1		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/26/1997

Labeler - HOMEOLAB USA INC (202032533)

Name	Address	ID/FEI	Business Operations
Establishment
HOMEOLAB USA INC		202032533	manufacture(60512-0050)

DRUG FACTS