Label: 70% ALCOHOL HAND SANITIZER- alcohol soap
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Contains inactivated NDC Code(s)
NDC Code(s): 50865-074-41, 50865-074-44 - Packager: Kutol Products Company, Inc.
- 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 February 26, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
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WARNINGS
For external use only.
Avoid contact with eyes. If eye contact occurs, flush eyes with water.
Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.
Keep out of reach of children. If swallowed, contact a physician or poison control center.
- DOSAGE & ADMINISTRATION
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INDICATIONS & USAGE
For handwashing to help reduce bacteria on the skin.
Avoid contact with eyes. If eye contact occurs, flush eyes with water.
Stop use if, in rare instances, redness or irritation develop. If condition persists for more than 72 hours, consult a physician.
Keep out of reach of children. If swallowed, contact a physician or poison control center.
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
70% ALCOHOL HAND SANITIZER
alcohol soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50865-074 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 CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) TRIISOPROPANOLAMINE (UNII: W9EN9DLM98) ALOE VERA LEAF (UNII: ZY81Z83H0X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50865-074-41 6 in 1 PACKET 02/27/2018 1 1000 mL in 1 BAG; Type 0: Not a Combination Product 2 NDC:50865-074-44 4 in 1 PACKET 02/27/2018 2 1000 mL in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 02/27/2018 Labeler - Kutol Products Company, Inc. (004236139) Establishment Name Address ID/FEI Business Operations Kutol Products Company, Inc. 004236139 manufacture(50865-074) , analysis(50865-074) , label(50865-074) , pack(50865-074)
