Label: INNER BEAUTY CLEAN- witch hazel gel
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Contains inactivated NDC Code(s)
NDC Code(s): 70220-010-01 - Packager: AMINI
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 23, 2015
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: WATER,ALOE BARBADENSIS LEAF JUICE,ALCOHOL,GLYCERIN,HYDROXYETHYLCELLULOSE,HYDROXYPROPYL CYCLODEXTRIN,ULMUS DAVIDIANA ROOT EXTRACT,AMARANTHUS CAUDATUS SEED EXTRACT,CENTELLA ASIATICA EXTRACT,FICUS CARICA (FIG) FRUIT EXTRACT,JUNIPERUS COMMUNIS FRUIT EXTRACT,RUBUS COREANUS FRUIT EXTRACT,ADONIS AMURENSIS/AKEBIA QUINATA/ALBIZIA JULIBRISSIN/ALTHAEA ROSEA/ANGELICA ACUTILOBA/ANGELICA ANOMALA/AQUILEGIA BUERGERIANA/ARTEMISIA PRINCEPS/ASTER CILIOSUS/ASTER SCABER/BRASSICA CAMPESTRIS/BROUSSONETIA KAZINOKI/CALLISTEPHUS CHINENSIS/CAMELLIA JAPONICA/CAMELLIA SINENSIS/CAMPSIS GRANDIFLORA/CARAGANA SINICA/CARTHAMUSTINCTORIUS/CASSIA OBTUSIFOLIA/CELOSIA CRISTATA/CERCIS CHINENSIS/CHAENOMELES SINENSIS/CHRYSANTHEMUM INDICUM/CHRYSANTHEMUM ZAWADSKII/CLEMATIS TERNIFLORA/COMMELINA COMMUNIS/CORNUS KOUSA/CORNUS OFFICINALIS/CORYDALIS INCISA/CORYDALIS TURTSCHANINOVII/CUCURBITA MOSCHATE/DENDROBIUM NOBILE/DIANTHUS CHINENSIS/ELSHOLTZIA SPLENDENS/EUPATORIUM LINDLEYANUM/FORSYTHIA KOREANA/FRITILLARIA USSURIENSIS/GARDENIA JASMINOIDES/GINKGO BILOBA/HELIANTHUS ANNUUS/HELIANTHUS TUBEROSUS/HEMEROCALLIS FULVA/HIBISCUS MUTABILIS/HIBISCUS SYRIACUS/HOSTA PLANTAGINAE/HYDRANGEA MACROPHYLLA/IMPATIENS BALSAMINA/IPOMEA HEDERACEA/IRIS PALLASII/IRIS PSEUDACORUS/KERRIA JAPONICA/LAGERSTROEMIA INDICA/LEONURUS SIBIRICUS/LESPEDEZA BICOLOR/LILIUM LANCIFOLIUM/LINDERA OBTUSILOBA/LIRIOPES MUSCARI/LONICERA JAPONICA/LYCORIS RADIATA/MAGNOLIA KOBUS/MAGNOLIA LILIFLORA/MALUS SIEBOLDII/NARCISSUS TAZETTA/NELUMBO NUCIFERA/OENOTHERA BIENNIS/PAEONIA LACTIFLORA/PAEONIA SUFFRUTICOSA/PAPAVER RHOEAS/PATRINIA SCABIOSIFOLIA/PAULOWNIA COREANA/PERSICARIA THUNBERGII/PETASITES JAPONICUS/PHYTOLACCA ESCULENTA/PLATYCODON GRANDIFLORUS/POLYGONUM ODORATUM/PONICIRUS TRIFOLIATA/PRUNUS ARMENIACA/PRUNUS MUME/PRUNUS PERSICA/PRUNUS SERRULATA/PRUNUS TOMENTOSA/PUERARIA LOBATA/RHODODENDRON MUCRONULATUM/ROBINIA PSEUDACACIA/ROSA MULTIFLORA/ROSA RUGOSA/SASA BOREALIS/SOPHORA JAPONICA/SPIRAEA PRUNIFOLIA/STYRAX JAPONICA/SYRINGA VULGARIS/TARAXACUM PLATYCARPUM/TULIPA EDULIS/VIOLA MANDSCHURICA/WEIGELA SUBSESSILIS/WISTERIA SINENSIS/ZANTHOXYLUM SCHINIFOLIUM/ZEA MAYS/ZINGIBER MIOGA/ZINNIA ELEGANS FLOWER EXTRACT,MORUS NIGRA LEAF EXTRACT,PUNICA GRANATUM EXTRACT,EUTERPE OLERACEA FRUIT EXTRACT,RUBUS CHAMAEMORUS SEED EXTRACT,VACCINIUM MYRTILLUS FRUIT EXTRACT,PRUNELLA VULGARIS EXTRACT,FUCUS VESICULOSUS EXTRACT,CAESALPINIA SAPPAN BARK EXTRACT,POGOSTEMON CABLIN LEAF EXTRACT,MYRISTICA FRAGRANS (NUTMEG) EXTRACT,DRABA NEMOROSA EXTRACT,CORYDALIS OCHOTENSIS EXTRACT,RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT,CHENOPODIUM ALBUM FLOWER EXTRACT,VACCINIUM ANGUSTIFOLIUM (BLUEBERRY) FRUIT EXTRACT,MORUS ALBA ROOT EXTRACT,FRAGARIA VESCA (STRAWBERRY) FRUIT EXTRACT,LACTUCA INDICA EXTRACT,SACCHARUM OFFICINARUM (SUGAR CANE) EXTRACT,PORTULACA OLERACEA EXTRACT,PUERARIA THUNBERGIANA ROOT EXTRACT,GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT,PAEONIA LACTIFLORA ROOT EXTRACT,CNIDIUM OFFICINALE ROOT EXTRACT,CODIUM FRAGILE EXTRACT,SALVIA MILTIORRHIZA FLOWER/LEAF/ROOT EXTRACT,EUCOMMIA ULMOIDES EXTRACT,CAULERPA LENTILLIFERA EXTRACT,PORIA COCOS EXTRACT,PANAX GINSENG ROOT EXTRACT,PRUNUS ARMENIACA (APRICOT) KERNEL EXTRACT,SAMBUCUS NIGRA FRUIT EXTRACT,CITRUS LIMON (LEMON) FRUIT EXTRACT ,CITRUS AURANTIUM DULCIS (ORANGE) FRUIT EXTRACT,LYCIUM BARBARUM FRUIT EXTRACT,MITRACARPUS SCABER EXTRACT,ARCTOSTAPHYLOS UVA URSI LEAF EXTRACT,ACER SACCHARUM (SUGAR MAPLE) EXTRACT,LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT,PRUNUS ARMENIACA (APRICOT) FRUIT EXTRACT,COIX LACRYMA-JOBI MA-YUEN SEED EXTRACT,PLANTAGO ASIATICA EXTRACT,SCUTELLARIA BAICALENSIS ROOT EXTRACT,RUBUS ELLIPITICUS ROOT EXTRACT,RUBUS FRUTICOSUS (BLACKBERRY) LEAF EXTRACT ,HAMAMELIS VIRGINIANA (WITCH HAZEL) WATER,SOLUBLE COLLAGEN,HYDROGENATED LECITHIN,SODIUM HYALURONATE,POLYGLYCERYL-10 LAURATE,SODIUM CITRATE,ALUMINUM LACTATE,BUTYLENE GLYCOL,ALLANTOIN,ETHYLHEXYLGLYCERIN,LACTOBACILLUS FERMENT,DIPOTASSIUM GLYCYRRHIZATE,CHLORHEXIDINE DIGLUCONATE,HYDROXYMETHOXYPHENYL PROPYLMET HYLMETHOXYBENZOFURAN,MALTODEXTRIN,CERAMIDE 3,XANTHAN GUM,FRAGRANCE
- PURPOSE
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WARNINGS
Warnings: 1. Stop using the product immediately if any of following symptoms appears, and consult a dermatologist as continuing to use the product may worsen the symptoms. 1) Red spots, swelling, itching or irritations during use 2) If above symptoms appeared to the applied area due to direct sunlight 2. Do not use on areas with scars, eczema or dermatitis 3. Storage and handling precautions 1) Close the lid after use 2) Keep away from the reach of children 3) Avoid storing high/low temperature and direct sunlight 4. Precautions during use 1) Use only on the vulva 2) Do not use the product for a prolonged period of time 3) Be careful if the affected area or the surrounding area is dirty 4) Do not use on children under 3 years of age 5) Avoid using during pregnancy and prior to the delivery as it may get into the newborn’s eyes during delivery
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
INNER BEAUTY CLEAN
witch hazel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70220-010 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL 0.68 mg in 80 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70220-010-01 80 mL in 1 CARTON; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 11/01/2015 Labeler - AMINI (689226857) Registrant - AMINI (689226857) Establishment Name Address ID/FEI Business Operations AMINI 689226857 repack(70220-010) Establishment Name Address ID/FEI Business Operations Kolmar Korea Co., Ltd. 689512611 manufacture(70220-010)
