Label: ICING- hand sanitizer gel
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Contains inactivated NDC Code(s)
NDC Code(s): 10827-0003-1 - Packager: Yusef Manufacturing Laboratories, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 10, 2010
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- PURPOSE
- SPL UNCLASSIFIED SECTION
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WARNINGS
Warning: Flammable. Do not use near fire, flame or while smoking. Do not store where temperature exceeds 120 F. For external use only. Avoid contact with eyes. In case of contact with eyes, flush with water. Discontinue this product if rash, redness or irritation occurs. If irritation persists, get immediate attention. Keep out of reach of children. DO NOT EAT.
Advertissement: Inflammable. Ne pas utiliser pres d'une fiamme, d'une etincelle ou en fumant. Ne pas garder a des temperatures depassant les 49 C (120 F). Pour usage exteme uniquement. Evitez tout contact avec les yeux. En cas de contact avec les yeux, rincez avec de l'eau. Arretez l'utilisation de ce produit en cas d'irritation. Si l'irritation persiste, consulter immediatement un medecin. gardez hors de portee des enfants. NE PAS INGERER.
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
- ACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
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INGREDIENTS AND APPEARANCE
ICING
hand sanitizer gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10827-0003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.62 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) TROLAMINE (UNII: 9O3K93S3TK) LACTOSE (UNII: J2B2A4N98G) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) FERRIC OXIDE RED (UNII: 1K09F3G675) (PHTHALOCYANINATO(2-)) COPPER (UNII: 3VEX9T7UT5) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10827-0003-1 28 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333 03/10/2010 Labeler - Yusef Manufacturing Laboratories, LLC (144150674) Registrant - Yusef Manufacturing Laboratories, LLC (144150674) Establishment Name Address ID/FEI Business Operations Yusef Manufacturing Laboratories, LLC 144150674 manufacture