Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 79363-701-04, 79363-701-08, 79363-701-16, 79363-701-28, view more79363-701-32 - Packager: REALCHEM MANUFACTURING
- 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 25, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient(s)
- Purpose
- Use
- Warnings
- Do not use
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WHEN USING
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. - STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79363-701 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL in 100 mL RAPIDGEL EZ1 (UNII: 33JH4A7R2K) 1 mL in 100 mL WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79363-701-28 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2020 2 NDC:79363-701-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2020 3 NDC:79363-701-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2020 4 NDC:79363-701-32 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2020 5 NDC:79363-701-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/30/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/01/2020 Labeler - REALCHEM MANUFACTURING (120491681) Establishment Name Address ID/FEI Business Operations REALCHEM MANUFACTURING 117584702 manufacture(79363-701) , pack(79363-701) , repack(79363-701) Establishment Name Address ID/FEI Business Operations REALCHEM MANUFACTURING 117742005 manufacture(79363-701) , pack(79363-701) , repack(79363-701) Establishment Name Address ID/FEI Business Operations REALCHEM MANUFACTURING 117828480 manufacture(79363-701) , pack(79363-701) , repack(79363-701) Establishment Name Address ID/FEI Business Operations REALCHEM MANUFACTURING 120491681 manufacture(79363-701) , pack(79363-701) , repack(79363-701)