KIDS RELIEF CALENDULA- calendula officinalis, echinacea angustifolia, hypericum perforatum, phytolacca decandra, cantharis, sulp

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ), ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8), HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB), PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG), LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT), SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)
Available from:
HOMEOLAB USA INC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
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. 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.
Authorization status:
unapproved homeopathic
Authorization number:
60512-9087-1, 60512-9087-2

KIDS RELIEF CALENDULA- calendula officinalis, echinacea angustifolia, hypericum

perforatum, phytolacca decandra, cantharis, sulphur cream

HOMEOLAB USA INC

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.

----------

DRUG FACTS

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 tube seal is broken.

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.

CARTON

TUBE

KIDS RELIEF CALENDULA

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

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 0 512-9 0 8 7

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CALENDULA O FFICINALIS FLO WERING TO P (UNII: 18 E7415PXQ) (CALENDULA

OFFICINALIS FLOWERING TOP - UNII:18 E7415PXQ)

CALENDULA OFFICINALIS

FLOWERING TOP

1 [hp_X]

in 50 g

ECHINACEA ANGUSTIFO LIA (UNII: VB0 6 AV5US8 ) (ECHINACEA ANGUSTIFOLIA -

UNII:VB0 6 AV5US8 )

ECHINACEA ANGUSTIFOLIA

1 [hp_X]

in 50 g

HYPERICUM PERFO RATUM (UNII: XK4IUX8 MNB) (HYPERICUM PERFORATUM -

UNII:XK4IUX8 MNB)

HYPERICUM PERFORATUM

3 [hp_X]

in 50 g

PHYTO LACCA AMERICANA RO O T (UNII: 11E6 VI8 VEG) (PHYTOLACCA AMERICANA

PHYTOLACCA AMERICANA

3 [hp_X]

HOMEOLAB USA INC

ROOT - UNII:11E6 VI8 VEG)

ROOT

in 50 g

LYTTA VESICATO RIA (UNII: 3Q0 34RO3BT) (LYTTA VESICATORIA -

UNII:3Q0 34RO3BT)

LYTTA VESICATORIA

3 [hp_X]

in 50 g

SULFUR (UNII: 70 FD1KFU70 ) (SULFUR - UNII:70 FD1KFU70 )

SULFUR

3 [hp_X]

in 50 g

Inactive Ingredients

Ingredient Name

Stre ng th

CARBO MER HO MO PO LYMER TYPE A (UNII: F6 8 VH75CJC)

CETEARETH-12 (UNII: 7V4MR24V5P)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

CETYL PALMITATE (UNII: 5ZA2S6 B0 8 X)

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

GLYCERIN (UNII: PDC6 A3C0 OX)

GLYCERYL CO CO ATE (UNII: WVK1CT59 9 4)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

IO DO PRO PYNYL BUTYLCARBAMATE (UNII: 6 0 3P14DHEB)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

ISO PRO PYL PALMITATE (UNII: 8 CRQ2TH6 3M)

O CTYLDO DECANO L (UNII: 46 1N1O6 14Y)

PEG-2 0 GLYCERYL STEARATE (UNII: MJV0 16 5YY8 )

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

SO RBITAN MO NO STEARATE (UNII: NVZ4I0 H58 X)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 0 512-9 0 8 7-1

1 in 1 CARTON

1

50 g in 1 TUBE

2

NDC:6 0 512-9 0 8 7-2

6 g in 1 TUBE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 3/15/20 12

Labeler -

HOMEOLAB USA INC (202032533)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

HOMEOLAB USA INC

20 20 32533

ma nufa c ture (6 0 512-9 0 8 7)

Revised: 2/2014

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