Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 74084-0003-1, 74084-0003-2 - Packager: Ongoong Co Ltd
- 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 28, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
For external use only.
Flammable, keep away from fire or flame.
When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.
Stop use and ask a doctor if significant irritation or sensitization develops.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74084-0003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 g in 100 mL Inactive Ingredients Ingredient Name Strength TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74084-0003-1 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/21/2020 2 NDC:74084-0003-2 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/21/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/21/2020 Labeler - Ongoong Co Ltd (695625965) Registrant - Ongoong Co Ltd (695625965) Establishment Name Address ID/FEI Business Operations Ongoong Co Ltd 695625965 label(74084-0003) , manufacture(74084-0003)