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

These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

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

USES

This homeopathic medicine is made from a combination of ingredients traditionally used to help:

- 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 film wrapper 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 hypersensitivity and/or allergy occurs.

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

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 - 77°F).

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.

LABEL

label

KIDS RELIEF CALENDULA
calendula officinalis, echinacea angustifolia, hypericum perforatum, phytolacca decandra, cantharis, sulphur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60512-9204
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:60512-9204-1	50 g in 1 JAR; Type 0: Not a Combination Product	11/07/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		11/07/2016

Labeler - HOMEOLAB USA INC (202032533)

Name	Address	ID/FEI	Business Operations
Establishment
HOMEOLAB USA INC		202032533	manufacture(60512-9204)

DRUG FACTS