Label: IASO SMART PACT 23- zinc oxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 75847-0004-1 - Packager: IASO Inc
- 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 March 2, 2018
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
mica, talc, titanium dioxide, silica, dimethicone, boron nitride, dimethicone/vinyl dimethicone crosspolymer, ci 77492, zinc myristate, cetyl caprylate, vinyl dimethicone/methicone silsesquioxane crosspolymer, aluminium hydroxide, stearic acid, aluminum starch octenylsuccinate, aluminum dimyristate, ci 77491, glyceryl rosinate, methicone, octyldodecyl myristate, c9-15 fluoroalcohol phosphate, magnesium myristate, methylparaben, dimethicone/methicone copolymer, fragrance, tocopheryl acetate, trimethylsiloxysilicate, ci 77499, propylparaben, lycium chinense fruit ext, cornus officinalis fruit ext, schizandra chinensis fruit ext
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
IASO SMART PACT 23
zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75847-0004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.0291 g in 1 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BORON NITRIDE (UNII: 2U4T60A6YD) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75847-0004-1 10 g in 1 PACKAGE; Type 0: Not a Combination Product 03/12/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/01/2013 Labeler - IASO Inc (688771690) Registrant - IASO Inc (688771690) Establishment Name Address ID/FEI Business Operations Kolmar Korea Co., Ltd 689847167 manufacture(75847-0004)