Label: 80% GEL HAND SANITIZER- alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 78044-200-01, 78044-200-02, 78044-200-03, 78044-200-04, view more78044-200-05, 78044-200-06, 78044-200-07 - Packager: CBIO Brand Distribution International 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 June 9, 2020
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- Active Ingredient(s)
- Purpose
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- Warnings
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive ingredients
- Package Label - Principal Display Panel
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INGREDIENTS AND APPEARANCE
80% GEL HAND SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78044-200 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 80 mL in 100 mL Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) RAPIDGEL EZ1 (UNII: 33JH4A7R2K) GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL in 100 mL WATER (UNII: 059QF0KO0R) SQUALANE (UNII: GW89575KF9) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:78044-200-01 100 mL in 1 TUBE; Type 0: Not a Combination Product 05/27/2020 2 NDC:78044-200-02 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/27/2020 3 NDC:78044-200-03 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/27/2020 4 NDC:78044-200-04 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/27/2020 5 NDC:78044-200-05 208198 mL in 1 DRUM; Type 0: Not a Combination Product 05/27/2020 6 NDC:78044-200-06 1003130 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product 05/27/2020 7 NDC:78044-200-07 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/27/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/27/2020 Labeler - CBIO Brand Distribution International Inc. (117495482) Registrant - CBIO Brand Distribution International Inc. (117495482)