Label: KIDS RELIEF CALENDULA- calendula officinalis, echinacea angustifolia, hypericum perforatum, phytolacca decandra, cantharis, sulphur cream
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Contains inactivated NDC Code(s)
NDC Code(s): 60512-9087-1, 60512-9087-2 - Packager: HOMEOLAB USA INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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 Label Information
Updated February 21, 2014
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- ACTIVE INGREDIENTS HPUS
- PURPOSE
- REFERENCES
- USES
- WARNINGS
- DIRECTIONS
- OTHER INFORMATION
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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
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INGREDIENTS AND APPEARANCE
KIDS RELIEF CALENDULA
calendula officinalis, echinacea angustifolia, hypericum perforatum, phytolacca decandra, cantharis, sulphur creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60512-9087 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60512-9087-1 1 in 1 CARTON 1 50 g in 1 TUBE 2 NDC:60512-9087-2 6 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/15/2012 Labeler - HOMEOLAB USA INC (202032533) Establishment Name Address ID/FEI Business Operations HOMEOLAB USA INC 202032533 manufacture(60512-9087)