Label: ADVANCED HAND SANITIZER- alcohol gel
- NDC Code(s): 63868-882-16, 63868-882-34, 63868-882-43, 63868-882-45
- Packager: CDMA
- 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.
Updated January 31, 2023
If you are a consumer or patient please visit this version.
- Active Ingredient
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Other information
- Inactive ingredients
SPL UNCLASSIFIED SECTION
*This product is not manufactured or distributed by GOJO Industries, Inc, distributer of Purell Advanced Hand Sanitizer.
**Effective at eliminating more than 99.99% of many common harmful germs and bacteria in as little as 15 seconds*
Distributed by CDMA, Inc.
43157 W Nine Mile
Novi, MI 48357
- principal display panel
INGREDIENTS AND APPEARANCE
ADVANCED HAND SANITIZER
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-882 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 water (UNII: 059QF0KO0R) GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CARBOMER COPOLYMER TYPE b (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) SULISOBENZONE (UNII: 1W6L629B4K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-882-16 59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/05/2021 2 NDC:63868-882-34 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/05/2021 3 NDC:63868-882-45 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/05/2021 4 NDC:63868-882-43 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/05/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/05/2021 Labeler - CDMA (011920774) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(63868-882) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(63868-882)