Label: GEL INSTANT HAND SANITIZER- alcohol soap
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Contains inactivated NDC Code(s)
NDC Code(s): 50865-370-27, 50865-370-36 - Packager: Kutol Products
- Category: HUMAN OTC DRUG LABEL
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 January 16, 2019
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- ACTIVE INGREDIENT
- PURPOSE
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INDICATIONS & USAGE
Uses / Utilisations: For handwashing to help reduce bacteria on the skin. Not for professional use in healthcare or food handling premises. / Pour le lavage des mains, afin de réduire les bactéries sur la peau. Ne pas utiliser à des fins professionelles dans les locaux de soins de santé ou de manipulation des aliments.
- KEEP OUT OF REACH OF CHILDREN
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WARNINGS
Warnings / Avertissements :
For external use only. FLAMMABLE. Keep away from heat or flame. Avoid contact with eyes. If eye contact occurs, flush eyes with water. Stop use if, in rare instances, redness or irritation develops. If condition persists for more than 72 hours, consult a physician. /
Pour usage externe seulement. INFLAMMABLE. Ne pas mettre a proximite d'un feu ou d'une flamme. Ne pas mettre dans les yeux. En cas de contact avec les yeux, rincer avec l'eau. Arrêtex l'utilisation en cas rares d'irritation ou de rougeru. Si les symptômes persistent plus de 72 heures, consultez en médecin. Garder hors de portée des enfants. En cas d'ingestion, consultez un médecin ou un centre antipoison.
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive Ingredients / Ingrédients Inactifs : water, glycerin, propylene glycol, ispropyl myristate, aloe barbadensis leaf juice, tocopheryl acetate (Vitamin E), isopropyl alcohol, carbomer, triisopropanolamine. / Eau, glycérine, propylèneglycol, myristate isopropylique, jus de feuille d'aloès barbadine, acétate tocophérylique (Vitamine E), alcool isopropylique, carbomère, triisopropanolamine.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GEL INSTANT HAND SANITIZER
alcohol soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50865-370 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.07 mg in 1 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL ALCOHOL (UNII: ND2M416302) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) TRIISOPROPANOLAMINE (UNII: W9EN9DLM98) ALOE VERA LEAF (UNII: ZY81Z83H0X) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) WATER (UNII: 059QF0KO0R) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50865-370-27 1000 mL in 1 BAG; Type 0: Not a Combination Product 09/15/2017 2 NDC:50865-370-36 1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/15/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/15/2017 Labeler - Kutol Products (004236139) Establishment Name Address ID/FEI Business Operations Kutol Products 004236139 manufacture(50865-370)