Label: ALPHA HANDRUB ANTISEPTIC HAND SANITIZER- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77959-202-01, 77959-202-04, 77959-202-20, 77959-202-25, view more77959-202-50, 77959-202-55 - Packager: Alpha Cleantech Labs Inc
- 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 November 17, 2020
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
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Warnings
Flammable, keep away from fire/flame
For external use onlyDo not use
• in children less than 2 months of age
• on open skin woundsWhen using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water
Stop use and ask a doctor if
• irritation and redness develop
• condition persists for more than 72 hours - Directions
- Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
ALPHA HANDRUB ANTISEPTIC HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77959-202 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 75 mL in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) GLYCERIN (UNII: PDC6A3C0OX) HYDROGEN PEROXIDE (UNII: BBX060AN9V) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77959-202-25 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/17/2020 2 NDC:77959-202-50 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/17/2020 3 NDC:77959-202-01 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/17/2020 4 NDC:77959-202-04 3785 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/17/2020 5 NDC:77959-202-20 18927 mL in 1 CONTAINER; Type 0: Not a Combination Product 11/17/2020 6 NDC:77959-202-55 208198 mL in 1 CONTAINER; Type 0: Not a Combination Product 11/17/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/17/2020 Labeler - Alpha Cleantech Labs Inc (204074603) Establishment Name Address ID/FEI Business Operations Alpha Cleantech Labs Inc 204074603 manufacture(77959-202)