Label: HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 79032-206-05, 79032-206-15 - Packager: Actalys
- 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 July 30, 2020
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- Official Label (Printer Friendly)
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500ml NDC: 79032-206-15
Use
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
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.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Place enough product on hands to cover all surfaces. Rub hands together until dry.
- Supervise children under 6 years of age when using this product to avoid swallowing.
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INGREDIENTS AND APPEARANCE
HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79032-206 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 350 mL in 500 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) 4.5 mL in 500 mL TROLAMINE (UNII: 9O3K93S3TK) 1 mL in 500 mL WATER (UNII: 059QF0KO0R) 141.85 mL in 500 mL HETEROTHECA INULOIDES FLOWER (UNII: W9NZ9OZF68) 0.1 mL in 500 mL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.75 mL in 500 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79032-206-15 20 in 1 BOX 07/30/2020 1 NDC:79032-206-05 500 mL in 1 BOTTLE; 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 07/30/2020 Labeler - Actalys (260814505) Registrant - Actalys (260814505) Establishment Name Address ID/FEI Business Operations Actalys 260814505 api manufacture(79032-206)
